Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302559
Recruitment Status : Completed
First Posted : October 5, 2017
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Skin Care
Interventions Other: Retinol Complex 0.5
Other: Facial cleanser
Other: Moisturizing lotion
Other: Sunscreen
Device: Skin Imaging
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Period Title: Overall Study
Started 29
Completed 23
Not Completed 6
Reason Not Completed
Adverse Event             2
Lost to Follow-up             1
Withdrew Consent             3
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
55  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
21
  91.3%
Male
2
   8.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Caucasian
11
  47.8%
Hispanic
3
  13.0%
Asian
8
  34.8%
Other
1
   4.3%
1.Primary Outcome
Title Change From Baseline in Overall Photodamage Score
Hide Description The investigator assessed the participant’s overall photodamage using a 10-point scale where None (0)= Facial skin is smooth to the touch, without significant fine/coarse line or skin tone unevenness in any areas (periocular, cheeks, forehead and perioral areas) to Severe (7 to 9)= Facial skin shows 3 or more areas (periocular, cheeks, forehead and perioral areas) of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (BL) 5.6  (0.9)
Change from BL at Week 12 -0.8  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Hide Description The investigator assessed the participant’s appearance of fine lines/wrinkles using a 10-point scale where None (0)= No fine lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (Forehead) 3.4  (1.5)
Change from BL at Week 12 (Forehead) -0.8  (1.2)
Baseline (Periocular) 4.7  (1.5)
Change from BL at Week 12 (Periocular) -1.0  (1.8)
Baseline (Cheeks) 3.6  (1.5)
Change from BL at Week 12 (Cheeks) -1.1  (1.3)
Baseline (Perioral) 4.0  (1.6)
Change from BL at Week 12 (Perioral) -0.9  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Forehead)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.005
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Periocular)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.02
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Cheeks)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.0006
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Perioral)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero
Statistical Test of Hypothesis P-Value 0.001
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Hide Description The investigator assessed the participant’s appearance of coarse lines/wrinkles using a 10-point scale where None (0)= No coarse lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (Forehead) 4.9  (1.4)
Change from BL at Week 12 (Forehead) -0.6  (1.1)
Baseline (Periocular) 6.0  (1.2)
Change from Baseline at Week 12 (Periocular) -0.7  (1.0)
Baseline (Cheeks) 3.5  (2.4)
Change from Baseline at Week 12 (Cheeks) -1.1  (1.1)
Baseline (Perioral) 4.4  (1.9)
Change from BL at Week 12 (Perioral) -0.2  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Forehead)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.02
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Periocular)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.006
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Cheeks)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Perioral)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.5
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in Tactile Roughness Score
Hide Description The investigator assessed the participant’s tactile roughness in the entire face using a 10-point scale where None (0)= No roughness of the treatment area; skin is completely smooth and pliable to Severe (7 to 9)= Marked roughness of the treatment area associated with stiff feeling at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 4.0  (1.7)
Change from BL at Week 12 -1.1  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.002
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale
Hide Description The investigator assessed the participant's skin roughness using the Allergan Skin Roughness Visual 5-Point Scale where None (0)= Smooth visual skin texture to Extreme (4)= Extremely coarse visual skin texture, crosshatched deep creases; extreme elastosis at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participant who applied study treatment and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.8  (1.1)
Change from BL at Week 12 -0.5  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.0008
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale
Hide Description The investigator assessed the participant's fine lines using the Allergan Fine Lines Visual 5-Point Scale where None (0)= No fine lines to Diffuse (4)= Diffuse superficial lines; crosshatching at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 4.0  (1.7)
Change from BL at Week 12 -0.3  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.02
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
7.Secondary Outcome
Title Investigator’s Global Improvement Assessment for Overall Photodamage
Hide Description The investigator assessed the global improvement in the participant’s overall photodamage compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Almost complete improvement of the condition with a trace of signs/symptoms remaining (approximately 95% or better overall improvement).
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.5  (0.7)
8.Secondary Outcome
Title Investigator’s Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Hide Description The investigator assessed the global improvement in the participant’s overall appearance of fine lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of fine lines/wrinkles (approximately 95% or better overall improvement).
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 12 (Forehead) 1.1  (0.6)
Week 12 (Periocular) 1.6  (0.9)
Week 12 (Cheeks) 1.3  (0.6)
Week 12 (Perioral) 1.2  (0.7)
9.Secondary Outcome
Title Investigator’s Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Hide Description The investigator assessed the global improvement in the participant’s overall appearance of coarse lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of coarse lines/wrinkles (approximately 95% or better overall improvement).
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 12 (Forehead) 0.8  (0.8)
Week 12 (Periocular) 1.6  (0.8)
Week 12 (Cheeks) 0.9  (0.8)
Week 12 (Perioral) 0.8  (0.8)
10.Secondary Outcome
Title Investigator’s Global Improvement Assessment for Tactile Roughness
Hide Description The investigator assessed the global improvement in the participant’s overall tactile roughness compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of tactile roughness (approximately 95% or better overall improvement).
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.3  (1.1)
11.Secondary Outcome
Title Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Hide Description Triplicate spectrophotometer readings were taken of the participant's face (Normal Skin and Target Lesions) at Baseline and Week 12. L* value scores range from 0=black to 100=white. An increase in the spectrophotometer L* values indicates improvement. A positive change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. Number analyzed is the number of participants with data available at the given time-point for analysis.
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description:
During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
Overall Number of Participants Analyzed 23
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline (Normal Skin) Number Analyzed 23 participants
62.0  (3.7)
Change from BL at Week 12 (Normal Skin) Number Analyzed 23 participants
0.3  (1.8)
Baseline (Target Lesion) Number Analyzed 23 participants
57.8  (5.7)
Change from BL at Week 12 (Target Lesion) Number Analyzed 16 participants
0.3  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Normal Skin)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.3
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Retinol Complex 0.5
Comments Change from Baseline at Week 12 (Target Lesion)
Type of Statistical Test Other
Comments Testing hypothesis is that the mean change from baseline is zero.
Statistical Test of Hypothesis P-Value 0.4
Comments Statistical significance is defined as a p-value ≤0.05.
Method Paired t-test
Comments [Not Specified]
Time Frame First study treatment application up to 12 weeks
Adverse Event Reporting Description Enrolled Population was used to determine the number of participants at risk for All-Cause Mortality. Safety Population, all enrolled participants who applied the test product, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
 
Arm/Group Title Retinol Complex 0.5
Hide Arm/Group Description During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.
All-Cause Mortality
Retinol Complex 0.5
Affected / at Risk (%)
Total   0/29 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Retinol Complex 0.5
Affected / at Risk (%)
Total   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Retinol Complex 0.5
Affected / at Risk (%)
Total   12/23 (52.17%) 
Skin and subcutaneous tissue disorders   
Burning sensation  1  5/23 (21.74%) 
Acne  1  2/23 (8.70%) 
Dry skin  1  4/23 (17.39%) 
Erythema  1  5/23 (21.74%) 
Rash  1  4/23 (17.39%) 
Skin exfoliation  1  2/23 (8.70%) 
Skin lesion  1  2/23 (8.70%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03302559     History of Changes
Other Study ID Numbers: SCRIC17-RET05
First Submitted: October 2, 2017
First Posted: October 5, 2017
Results First Submitted: April 30, 2019
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019