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Trial record 1 of 1 for:    NCT01787461
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A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure

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ClinicalTrials.gov Identifier: NCT01787461
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Photodamaged Skin
Interventions Dietary Supplement: Imedeen
Dietary Supplement: Placebo
Enrollment 194
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Period Title: Overall Study
Started 96 98
Completed 82 89
Not Completed 14 9
Reason Not Completed
Adverse Event             4             3
Lost to Follow-up             3             2
No longer met eligibility criteria             1             0
Withdrawal by Subject             3             4
Protocol Violation             3             0
Arm/Group Title Placebo Imedeen Total
Hide Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 95 98 193
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least one dose of the study treatments.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 98 participants 193 participants
52.5  (7.38) 52.7  (6.58) 52.6  (6.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 98 participants 193 participants
Female
95
 100.0%
98
 100.0%
193
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24
Hide Description IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline (n=93,97) 6.04  (1.45) 5.81  (1.30)
Change at Week 24 (n=92,95) 0.6  (1.28) 0.7  (1.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-0.16 to 0.44
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24
Hide Description IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 94
Mean (Standard Deviation)
Unit of Measure: units on scale
-0.2  (0.86) -0.1  (0.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.568
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.037
Confidence Interval (2-Sided) 95%
-0.19 to 0.27
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12
Hide Description IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline (n=93,97) 6.04  (1.45) 5.81  (1.30)
Change at Week 12 (n=92,95) 0.4  (1.14) 0.4  (1.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.797
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.25 to 0.33
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24
Hide Description Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or "bags" under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.
Time Frame Baseline, Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline: Fine L/W Periocular A (n=93,97) 5.95  (1.50) 5.79  (1.44)
Baseline: Fine L/W Perioral A (n= 93,97) 4.89  (1.78) 4.69  (1.65)
Baseline: Under eye dc or bags(n= 93,97) 5.68  (1.55) 5.34  (1.44)
Baseline: MH (n=93,97) 4.95  (1.71) 5.06  (1.51)
Baseline: Sallowness/yellowing (n=93,97) 3.41  (1.42) 3.51  (1.33)
Baseline: Roughness/texture (n=93,97) 3.10  (1.66) 2.77  (1.50)
Change at Week 12: Fine L/W Periocular A(n= 92,95) 0.5  (1.04) 0.5  (1.09)
Change at Week 12: Fine L/W Perioral A(n= 92,95) 0.4  (1.01) 0.4  (1.07)
Change at Week 12: Under eye dc or bags (n= 92,95) 0.5  (1.28) 0.3  (1.38)
Change at Week 12: MH (n= 92,95) 0.3  (1.38) 0.3  (1.42)
Change at Week 12: Sallowness/yellowing (n= 92,95) 0.4  (1.46) 0.4  (1.45)
Change at Week 12: Roughness/texture (n= 92,95) 0.4  (1.63) 0.2  (1.45)
Change at Week 24: Fine L/W Periocular A(n= 92,95) 0.7  (1.31) 0.8  (1.26)
Change at Week 24: Fine L/W Perioral A(n= 92,95) 0.4  (1.14) 0.5  (1.09)
Change at Week 24: Under eye dc or bags (n= 92,95) 0.7  (1.66) 0.6  (1.37)
Change at Week 24: MH (n= 92,95) 0.7  (1.32) 0.7  (1.36)
Change at Week 24: Sallowness/yellowing (n= 92,95) 1.0  (1.43) 1.0  (1.45)
Change at Week 24: Roughness/texture (n= 92,95) 0.8  (1.65) 0.5  (1.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.965
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.29 to 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.674
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.20 to 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.916
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.35 to 0.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.915
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.39 to 0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.672
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.40 to 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.655
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.27 to 0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.23 to 0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.14 to 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.669
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.28 to 0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.32 to 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.684
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.34 to 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.886
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.35 to 0.30
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24
Hide Description Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.
Time Frame Baseline, Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline: Decolletage-Crepyness (n=93,97) 4.65  (1.77) 4.56  (1.60)
Baseline: Decolletage-MH (n=93,97) 5.09  (1.80) 5.08  (1.65)
Baseline: Back of Hands–Crepyness (n=93,97) 5.37  (1.43) 5.19  (1.42)
Baseline: Back of Hands-MH (n=93,97) 3.96  (1.53) 3.92  (1.69)
Change at Week 12: Decolletage–Crepyness (n=92,95) 0.2  (1.23) 0.2  (1.49)
Change at Week 12: Decolletage-MH (n=92,95) 0.4  (1.36) 0.5  (1.20)
Change at Week 12:Back of Hands–Crepyness(n=92,95) 0.6  (1.39) 0.5  (1.48)
Change at Week 12: Back of Hands-MH (n=92,95) -0.2  (1.09) 0.3  (1.08)
Change at Week 24: Decolletage–Crepyness (n=92,95) 0.7  (1.56) 0.7  (1.36)
Change at Week 24: Decolletage-MH (n=92,95) 0.6  (1.43) 0.6  (1.14)
Change at Week 24:Back of Hands–Crepyness(n=92,95) 0.7  (1.39) 0.7  (1.45)
Change at Week 24: Back of Hands-MH (n=92,95) 0.1  (1.20) 0.4  (1.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Decolletage–Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.901
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.33 to 0.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.399
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-0.19 to 0.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Back of Hands–Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.875
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.38 to 0.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.13 to 0.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Decolletage–Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.876
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.33 to 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.789
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.29 to 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.901
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.31 to 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.04 to 0.72
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Participants Improvement Assessment of Face at Week 12 and 24
Hide Description Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
Time Frame Baseline, Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline: OA of facial skin (n=93,97) 5.67  (1.83) 5.60  (1.62)
Baseline: Fine L/W (n=93,97) 6.51  (2.11) 6.46  (1.89)
Baseline: Under eye dc or bags (n=93,97) 5.80  (2.66) 5.82  (2.64)
Baseline: Discoloration (n=93,97) 5.85  (2.42) 6.59  (2.23)
Baseline: Complexion/Glow (n=93,97) 5.19  (2.00) 5.02  (1.75)
Baseline: Smoothness (n=93,97) 6.69  (1.92) 6.49  (1.86)
Improvement Week 12: OA of facial skin (n=92,96) 0.7  (1.06) 0.8  (0.92)
Improvement Week 12: Fine L/W (n=92,96) 0.4  (0.84) 0.6  (0.89)
Improvement Week 12: Under eye dc or bags(n=92,96) 0.3  (0.72) 0.3  (0.95)
Improvement Week 12: Discoloration (n=91,95) 0.3  (0.80) 0.4  (1.01)
Improvement Week 12: Complexion/Glow (n=92,96) 0.7  (0.83) 0.7  (0.86)
Improvement Week 12: Smoothness (n=92,96) 0.9  (1.01) 1.0  (0.97)
Improvement Week 24: OA of facial skin (n=92,96) 0.8  (1.23) 1.0  (1.26)
Improvement Week 24: Fine L/W (n=92,96) 0.6  (1.01) 0.8  (1.18)
Improvement Week 24: Under eye dc or bags(n=92,96) 0.4  (0.88) 0.5  (1.08)
Improvement Week 24: Discoloration (n=91,93) 0.3  (0.97) 0.5  (1.11)
Improvement Week 24: Complexion/Glow (n=92,96) 0.8  (1.16) 0.9  (1.12)
Improvement Week 24: Smoothness (n=92,96) 1.1  (1.22) 1.2  (1.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.083
Confidence Interval (2-Sided) 95%
-0.10 to 0.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.445
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.121
Confidence Interval (2-Sided) 95%
-0.08 to 0.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.318
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.205
Confidence Interval (2-Sided) 95%
0.01 to 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.012
Confidence Interval (2-Sided) 95%
-0.15 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.018
Confidence Interval (2-Sided) 95%
-0.23 to 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.432
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.059
Confidence Interval (2-Sided) 95%
-0.13 to 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.833
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.030
Confidence Interval (2-Sided) 95%
-0.13 to 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.171
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.226
Confidence Interval (2-Sided) 95%
0.06 to 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.796
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.020
Confidence Interval (2-Sided) 95%
-0.16 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.942
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.033
Confidence Interval (2-Sided) 95%
-0.23 to 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.405
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.118
Confidence Interval (2-Sided) 95%
-0.05 to 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.687
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.061
Confidence Interval (2-Sided) 95%
-0.14 to 0.26
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24
Hide Description Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
Time Frame Baseline, Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline: Decolletage-Overall (n=93,97) 5.34  (2.08) 5.19  (1.92)
Baseline: Decolletage-W/C (n=93,97) 5.59  (2.35) 5.48  (2.22)
Baseline: Decolletage-Discoloration (n=93,97) 5.88  (2.59) 6.06  (2.21)
Baseline: Back of Hands-Overall (n=93,97) 4.89  (2.15) 4.89  (1.98)
Baseline: Back of Hands - Fine L/W (n=93,97) 6.23  (2.56) 6.53  (2.25)
Baseline: Back of Hands – Discoloration (n=93,97) 5.91  (2.62) 5.83  (2.56)
Baseline: Body – Dryness Overall (n=93,97) 5.34  (2.23) 5.15  (2.03)
Improvement Week 12: Decolletage-Overall (n=92,96) 0.3  (0.70) 0.5  (0.75)
Improvement Week 12: Decolletage-W/C (n=92,96) 0.2  (0.67) 0.4  (0.78)
Improvement Week 12: DD (n=87,94) 0.1  (0.57) 0.3  (0.69)
Improvement Week 12: BOH-Overall (n=92,96) 0.3  (0.68) 0.4  (0.92)
Improvement Week 12: BOH - Fine L/W (n=92,96) 0.2  (0.65) 0.4  (0.90)
Improvement Week 12: BOH – Discoloration (n=88,94) 0.2  (0.69) 0.3  (0.82)
Improvement Week 12: BD Overall (n=91,96) 0.6  (0.96) 0.5  (1.06)
Improvement Week 24: Decolletage-Overall (n=92,96) 0.5  (1.00) 0.7  (1.03)
Improvement Week 24: Decolletage-W/C (n=92,96) 0.5  (0.94) 0.7  (0.98)
Improvement Week 24: DD (n=88,91) 0.3  (0.90) 0.6  (1.08)
Improvement Week 24:BOH-Overall (n=92,96) 0.5  (0.99) 0.7  (1.08)
Improvement Week 24: BOH - Fine L/W (n=92,96) 0.4  (0.93) 0.6  (1.02)
Improvement Week 24: BOH – Discoloration (n=91,91) 0.3  (0.94) 0.5  (0.97)
Improvement Week 24: BD Overall (n=92,96) 0.7  (1.13) 0.7  (1.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.384
Confidence Interval (2-Sided) 95%
0.23 to 0.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.248
Confidence Interval (2-Sided) 95%
0.09 to 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.057
Confidence Interval (2-Sided) 95%
-0.11 to 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.096
Confidence Interval (2-Sided) 95%
-0.31 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.100
Confidence Interval (2-Sided) 95%
-0.05 to 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Back of Hands – Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.294
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.031
Confidence Interval (2-Sided) 95%
-0.19 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 12, Body – Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.857
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.035
Confidence Interval (2-Sided) 95%
-0.20 to 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.206
Confidence Interval (2-Sided) 95%
0.02 to 0.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.193
Confidence Interval (2-Sided) 95%
-0.02 to 0.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.205
Confidence Interval (2-Sided) 95%
0.07 to 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.614
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.003
Confidence Interval (2-Sided) 95%
-0.13 to 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.693
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.011
Confidence Interval (2-Sided) 95%
-0.18 to 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Back of Hands – Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.762
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value 0.079
Confidence Interval (2-Sided) 95%
-0.06 to 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Improvement Week 24, Body – Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Weighted Gamma Statistic
Estimated Value -0.013
Confidence Interval (2-Sided) 95%
-0.16 to 0.13
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24
Hide Description DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).
Time Frame Baseline, Week 6, 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: microsecond
Baseline: Left Cheek (n=93,97) 231.7  (54.58) 238.7  (69.69)
Change at Week 6: Left Cheek (n=93,97) -5.2  (48.13) 1.9  (70.39)
Change at Week 12: Left Cheek (n=87,92) 16.7  (52.70) 20.0  (69.01)
Change at Week 18: Left Cheek (n=85,91) 35.1  (47.03) 35.5  (70.18)
Change at Week 24: Left Cheek (n=85,91) 33.1  (53.86) 29.1  (71.44)
Baseline: Left Inner Arm (n=93,97) 150.0  (41.37) 157.2  (52.72)
Change at Week 6: Left Inner Arm (n=93,97) -10.6  (48.51) -3.7  (54.36)
Change at Week 12: Left Inner Arm (n=87,92) -5.2  (69.84) 4.4  (61.24)
Change at Week 18: Left Inner Arm (n=85,91) 15.3  (45.69) 15.7  (55.30)
Change at Week 24: Left Inner Arm (n=85,91) 15.4  (39.36) 12.0  (53.89)
Baseline: Left Outer Arm (n=93,97) 120.0  (49.37) 130.0  (61.83)
Change at Week 6: Left Outer Arm (n=93,97) -6.4  (42.13) -3.5  (57.26)
Change at Week 12: Left Outer Arm (n=87,92) -1.5  (45.13) 1.7  (57.49)
Change at Week 18: Left Outer Arm (n=85,91) 9.8  (45.27) 14.0  (58.47)
Change at Week 24: Left Outer Arm (n=85,91) 9.4  (48.60) 10.2  (50.92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.587
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.93
Confidence Interval (2-Sided) 95%
-10.32 to 18.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.08
Confidence Interval (2-Sided) 95%
-14.49 to 12.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.453
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.57
Confidence Interval (2-Sided) 95%
-16.14 to 8.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.16
Confidence Interval (2-Sided) 95%
-22.92 to 4.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.61
Confidence Interval (2-Sided) 95%
-10.07 to 15.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.74
Confidence Interval (2-Sided) 95%
-11.67 to 23.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.299
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.98
Confidence Interval (2-Sided) 95%
-17.29 to 5.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.07
Confidence Interval (2-Sided) 95%
-20.04 to 1.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.776
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.82
Confidence Interval (2-Sided) 95%
-14.39 to 10.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.603
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.33
Confidence Interval (2-Sided) 95%
-15.96 to 9.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.82
Confidence Interval (2-Sided) 95%
-15.23 to 7.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.225
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.75
Confidence Interval (2-Sided) 95%
-17.70 to 4.20
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24
Hide Description Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).
Time Frame Baseline, Week 6, 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: gram per square meter per hour
Baseline: Left Cheek (n=93,97) 11.7  (5.27) 11.0  (5.04)
Change at Week 6: Left Cheek (n=93,97) -0.0  (5.21) 0.4  (4.34)
Change at Week 12: Left Cheek (n=87,92) 0.0  (3.72) 0.8  (4.71)
Change at Week 18: Left Cheek (n=85,91) 0.2  (3.84) 0.8  (4.35)
Change at Week 24: Left Cheek (n=85,91) -0.4  (4.15) 0.4  (4.29)
Baseline: Left Inner Arm (n=93,97) 4.8  (2.00) 4.4  (1.90)
Change at Week 6: Left Inner Arm (n=93,97) -0.3  (1.86) -0.3  (2.46)
Change at Week 12: Left Inner Arm (n=87,92) -0.1  (1.79) 0.1  (1.67)
Change at Week 18: Left Inner Arm (n=85,91) -0.1  (1.41) 0.0  (1.80)
Change at Week 24: Left Inner Arm (n=85,91) -0.4  (1.63) -0.2  (1.72)
Baseline: Left Outer Arm (n=93,97) 4.6  (1.98) 4.1  (1.57)
Change at Week 6: Left Outer Arm (n=93,97) -0.2  (1.38) -0.2  (1.81)
Change at Week 12: Left Outer Arm (n=87,92) -0.1  (1.53) -0.2  (1.67)
Change at Week 18: Left Outer Arm (n=85,91) -0.0  (1.39) -0.1  (1.72)
Change at Week 24: Left Outer Arm (n=85,91) -0.4  (1.64) -0.4  (1.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
-0.46 to 2.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.12 to 2.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.01 to 1.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.20 to 2.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.36 to 0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-0.07 to 0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.14 to 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-0.06 to 0.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.17 to 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.594
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.32 to 0.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.20 to 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.17 to 0.64
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Skin Thickness at Week 6, 12,18 and 24
Hide Description Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).
Time Frame Baseline, Week 6, 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: micrometer
Baseline: Left Cheek (n=93,97) 1568.2  (234.01) 1531.1  (243.04)
Change at Week 6: Left Cheek (n=89,95) 2.4  (169.50) -33.9  (164.03)
Change at Week 12: Left Cheek (n=87,92) 11.3  (167.01) -37.1  (169.86)
Change at Week 18: Left Cheek (n=84,90) -21.7  (173.71) -45.8  (169.60)
Change at Week 24: Left Cheek (n=82,90) -55.6  (225.02) -81.1  (230.14)
Baseline: Left Inner Arm (n=93,96) 1101.8  (159.25) 1076.4  (137.32)
Change at Week 6: Left Inner Arm (n=91,96) 4.7  (94.41) 3.0  (86.69)
Change at Week 12: Left Inner Arm (n=87,91) -11.1  (102.32) -15.6  (92.83)
Change at Week 18: Left Inner Arm (n=84,88) -16.6  (117.88) -43.2  (108.18)
Change at Week 24: Left Inner Arm (n=82,89) -73.2  (126.50) -66.6  (126.87)
Baseline: Left Outer Arm (n=93,96) 1349.4  (191.23) 1332.2  (169.61)
Change at Week 6: Left Outer Arm (n=92,96) 9.1  (106.38) 17.0  (100.85)
Change at Week 12: Left Outer Arm (n=87,91) 9.5  (101.58) 5.2  (95.81)
Change at Week 18: Left Outer Arm (n=84,89) -3.3  (117.71) -23.1  (120.42)
Change at Week 24: Left Outer Arm (n=82,89) -55.3  (144.09) -55.3  (135.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.266
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -25.16
Confidence Interval (2-Sided) 95%
-69.63 to 19.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.210
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -28.79
Confidence Interval (2-Sided) 95%
-73.99 to 16.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.753
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.78
Confidence Interval (2-Sided) 95%
-56.55 to 40.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.632
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -14.90
Confidence Interval (2-Sided) 95%
-76.32 to 46.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.715
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.54
Confidence Interval (2-Sided) 95%
-19.94 to 29.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.648
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.35
Confidence Interval (2-Sided) 95%
-21.04 to 33.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -16.49
Confidence Interval (2-Sided) 95%
-48.81 to 15.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.402
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 14.42
Confidence Interval (2-Sided) 95%
-19.50 to 48.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 12.43
Confidence Interval (2-Sided) 95%
-15.49 to 40.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.916
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
-26.44 to 29.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.566
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.88
Confidence Interval (2-Sided) 95%
-43.81 to 24.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.667
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 8.58
Confidence Interval (2-Sided) 95%
-30.78 to 47.94
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)
Hide Description Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).
Time Frame Baseline, Week 6, 12, 18, 24
Hide Outcome Measure Data
Hide Analysis Population Description
m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively.
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description:
Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
Overall Number of Participants Analyzed 93 97
Mean (Standard Deviation)
Unit of Measure: micrometer
Baseline: Left Cheek (n=58,59) 10.5  (4.05) 10.3  (3.78)
Change at Week 6: Left Cheek (n=57,59) -0.1  (4.43) -0.7  (5.13)
Change at Week 12: Left Cheek (n=54,55) -0.1  (4.49) -0.8  (4.34)
Change at Week 18: Left Cheek (n=49,52) -1.8  (5.68) -3.3  (6.22)
Change at Week 24: Left Cheek (n=49,53) -2.5  (5.68) -3.3  (5.42)
Baseline: Left Inner Arm (n=58,58) 28.0  (6.96) 29.2  (8.41)
Change at Week 6: Left Inner Arm (n=57,58) -1.0  (10.20) 1.2  (11.61)
Change at Week 12: Left Inner Arm (n=54,54) 0.3  (8.73) -0.7  (10.05)
Change at Week 18: Left Inner Arm (n=49,50) -4.5  (10.73) -4.6  (13.87)
Change at Week 24: Left Inner Arm (n=49,52) -6.6  (10.98) -4.9  (11.64)
Baseline: Left Outer Arm (n=58,58) 19.5  (5.82) 19.4  (6.66)
Change at Week 6: Left Outer Arm (n=58,58) -0.2  (7.47) 0.0  (7.75)
Change at Week 12: Left Outer Arm (n=54,54) -0.5  (6.61) -2.0  (7.93)
Change at Week 18: Left Outer Arm (n=49,51) -2.6  (9.01) -3.6  (10.10)
Change at Week 24: Left Outer Arm (n=49,52) -4.5  (9.45) -3.9  (9.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.458
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-2.21 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.497
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-2.07 to 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-3.05 to 0.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-2.11 to 1.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
-2.34 to 4.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.243
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.85
Confidence Interval (2-Sided) 95%
-4.96 to 1.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.453
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-4.96 to 2.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
-2.79 to 3.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.987
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-2.44 to 2.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.42
Confidence Interval (2-Sided) 95%
-3.69 to 0.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.630
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-3.41 to 2.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
Comments Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.576
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
-2.06 to 3.68
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Placebo Imedeen
Hide Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
All-Cause Mortality
Placebo Imedeen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Imedeen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/95 (0.00%)   2/98 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  0/95 (0.00%)  1/98 (1.02%) 
Vascular disorders     
Thrombosis * 1  0/95 (0.00%)  1/98 (1.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Imedeen
Affected / at Risk (%) Affected / at Risk (%)
Total   24/95 (25.26%)   29/98 (29.59%) 
Gastrointestinal disorders     
Diarrhoea * 1  1/95 (1.05%)  2/98 (2.04%) 
Nausea * 1  3/95 (3.16%)  4/98 (4.08%) 
Vomiting * 1  2/95 (2.11%)  1/98 (1.02%) 
Infections and infestations     
Gastroenteritis * 1  3/95 (3.16%)  1/98 (1.02%) 
Nasopharyngitis * 1  3/95 (3.16%)  8/98 (8.16%) 
Tooth infection * 1  0/95 (0.00%)  2/98 (2.04%) 
Upper respiratory tract infection * 1  4/95 (4.21%)  3/98 (3.06%) 
Injury, poisoning and procedural complications     
Limb injury * 1  0/95 (0.00%)  2/98 (2.04%) 
Muscle strain * 1  0/95 (0.00%)  2/98 (2.04%) 
Procedural pain * 1  3/95 (3.16%)  2/98 (2.04%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  3/95 (3.16%)  1/98 (1.02%) 
Pain in extremity * 1  0/95 (0.00%)  2/98 (2.04%) 
Nervous system disorders     
Headache * 1  3/95 (3.16%)  1/98 (1.02%) 
Psychiatric disorders     
Depression * 1  0/95 (0.00%)  3/98 (3.06%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  3/95 (3.16%)  2/98 (2.04%) 
Sinus congestion * 1  1/95 (1.05%)  2/98 (2.04%) 
Skin and subcutaneous tissue disorders     
Acne * 1  1/95 (1.05%)  2/98 (2.04%) 
Dermatitis contact * 1  0/95 (0.00%)  5/98 (5.10%) 
Erythema * 1  2/95 (2.11%)  0/98 (0.00%) 
Pruritus * 1  2/95 (2.11%)  1/98 (1.02%) 
Rash * 1  3/95 (3.16%)  0/98 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01787461    
Other Study ID Numbers: B5271003
First Submitted: December 5, 2012
First Posted: February 8, 2013
Results First Submitted: March 5, 2015
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015