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Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging

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ClinicalTrials.gov Identifier: NCT00974480
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : December 15, 2010
Last Update Posted : September 20, 2011
Sponsor:
Collaborator:
Innovaderm Research Inc.
Information provided by (Responsible Party):
Robert BISSONNETTE, Cosmetique Active International

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Skin Aging
Interventions Other: Redermic
Drug: Tretinoin (Rejuva-A)
Enrollment 120
Recruitment Details Subjects were recruited from September 2009 to January 2010 at a research clinic.
Pre-assignment Details  
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description Cream applied twice a day every day, morning and evening for 24 weeks. Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks. Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Period Title: Overall Study
Started 40 40 40
Completed 29 33 30
Not Completed 11 7 10
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A Total
Hide Arm/Group Description Cream applied twice a day every day, morning and evening for 24 weeks. Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks. Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning. Total of all reporting groups
Overall Number of Baseline Participants 40 40 40 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
40
 100.0%
40
 100.0%
120
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 40 participants 120 participants
49.85  (3.18) 51.15  (3.20) 50.53  (2.84) 50.51  (3.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
Female
40
 100.0%
40
 100.0%
40
 100.0%
120
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 40 participants 40 participants 40 participants 120 participants
40 40 40 120
Skin aging measured with photonumeric scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 40 participants 40 participants 40 participants 120 participants
22.23  (7.10) 21.88  (5.83) 22.14  (5.13) 22.08  (6.06)
[1]
Measure Description: Scoring was accomplished by matching each part of the face (forehead, glabella, corners of the mouth, nasal labial fold, crow's feet, below eyes and upper lip) to photographs in the scales and reporting the appropriate number in the tables. All individual scores were added to obtain the total score (Less signs of skin aging = 0, more signs of skin aging = 41.6).
Transepidermal water loss (TEWL)   [1] 
Mean (Standard Deviation)
Unit of measure:  G / m² / h
Number Analyzed 40 participants 40 participants 40 participants 120 participants
9.90  (3.32) 9.61  (2.95) 9.71  (2.47) 9.74  (2.91)
[1]
Measure Description: Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study.
Skin hydration (conductance)   [1] 
Mean (Standard Deviation)
Unit of measure:  µsiemens (µmho)
Number Analyzed 40 participants 40 participants 40 participants 120 participants
51.00  (25.58) 64.35  (42.44) 57.25  (26.54) 57.53  (32.64)
[1]
Measure Description:

Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe.

Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration.

Skin elasticity   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilo Pascals
Number Analyzed 40 participants 40 participants 40 participants 120 participants
20.61  (10.83) 19.27  (8.51) 20.61  (9.75) 20.16  (9.68)
[1]
Measure Description: Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy.
Crow's feet replicas - area ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm²
Number Analyzed 40 participants 40 participants 40 participants 120 participants
7.98  (6.31) 5.87  (4.78) 9.28  (7.71) 7.53  (5.52)
[1]
Measure Description: An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling.
Clinical skin evaluation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 40 participants 40 participants 120 participants
29.05  (5.52) 29.20  (5.96) 28.65  (6.06) 28.97  (5.81)
[1]
Measure Description: A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses.
Sensitivity of the face evaluated by subject   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 40 participants 40 participants 120 participants
Pruritus 0.94  (1.51) 1.01  (1.88) 0.65  (1.73) 0.87  (1.71)
Tingling 0.99  (1.51) 0.69  (1.28) 1.04  (1.77) 0.91  (1.53)
Burning 0.83  (1.67) 0.55  (1.27) 0.45  (1.19) 0.61  (1.39)
Tightness 1.56  (2.02) 1.62  (2.21) 1.30  (2.47) 1.49  (2.23)
[1]
Measure Description:

Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately.

Each score is from 0 = absent to 10 important.

Facial skin self-evaluation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 40 participants 40 participants 120 participants
Hydration 4.65  (2.01) 4.61  (1.81) 4.98  (1.55) 4.75  (1.79)
Firmness 4.67  (2.00) 5.34  (2.27) 4.62  (1.60) 4.88  (1.99)
Radiance 5.14  (1.72) 4.86  (1.69) 5.01  (2.10) 5.00  (1.83)
Softness 5.54  (1.54) 5.10  (2.19) 5.24  (1.93) 5.29  (1.90)
Comfort 5.39  (1.97) 5.75  (1.93) 6.31  (2.48) 5.82  (2.16)
Smoothness 6.20  (2.02) 6.53  (2.25) 6.51  (1.95) 6.41  (2.07)
Fine Lines 5.06  (1.85) 5.52  (2.12) 5.11  (2.12) 5.23  (2.03)
Wrinkles 5.14  (2.14) 5.67  (2.15) 5.06  (2.17) 5.29  (2.15)
Spots 2.92  (2.31) 3.97  (2.60) 4.17  (2.81) 3.68  (2.62)
Roughness 2.65  (2.14) 3.02  (2.62) 2.50  (2.14) 2.72  (2.31)
Imperfections 4.73  (2.41) 5.08  (2.18) 5.24  (2.57) 5.01  (2.38)
Dryness 5.01  (2.32) 5.15  (2.34) 4.35  (2.65) 4.83  (2.45)
Redness 3.04  (2.65) 3.00  (3.09) 2.92  (3.00) 2.99  (2.89)
[1]
Measure Description: A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important
Tolerance evaluated by investigator   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 40 participants 40 participants 120 participants
Scaling 0.08  (0.27) 0.05  (0.22) 0.03  (0.16) 0.05  (0.22)
Dryness 0.13  (0.33) 0.10  (0.30) 0.15  (0.36) 0.13  (0.33)
Erythema 0.05  (0.32) 0.0  (0.0) 0.08  (0.27) 0.04  (0.24)
Burning and itching 0.13  (0.33) 0.18  (0.59) 0.08  (0.27) 0.13  (0.42)
[1]
Measure Description:

Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale.

Scaling, Dryness and Erythema Evaluations

- None (0) - Very Severe = (4)

Burning and Itching Evaluation Scale

  • None (0) = Normal, no discomfort
  • Mild (1) = Slight discomfort that is not bothersome
  • Moderate (2) = Discomfort that is somewhat bothersome
  • Marked (3) = Discomfort that is bothersome and that occasionally interferes with normal daily activities
  • Severe (4) = Continuous discomfort that interferes with normal daily activities
1.Primary Outcome
Title Skin Aging Measured With the Photonumeric Scale.
Hide Description Scoring was accomplished by matching each part of the face (forehead, glabella, corners of the mouth, nasal labial fold, crow's feet, below eyes and upper lip) to photographs in the scales and reporting the appropriate number in the tables. All individual scores were added to obtain the total score (Less signs of skin aging = 0, more signs of skin aging = 41.6).
Time Frame 12, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 21.25  (6.60) 21.36  (5.93) 21.21  (5.29)
Week 24 21.03  (6.81) 20.92  (5.75) 21.31  (5.26)
2.Secondary Outcome
Title Photographic Evaluation by a Panel of Blinded Dermatologists.
Hide Description

A blinded panel of two dermatologists had to identify independently which of the two photographs had an improvement or if there was no noticeable difference between them. The two photographs of each subject were randomized to keep the blind.

When the Week 24 photograph was selected as the one showing an improvement, it was scored by the statistician as “improvement”. When the Day 0 photograph was selected as the one showing an improvement, it was scored by the statistician as “worsening”. When there was no noticeable difference between the photographs, it was scored as “stable”.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT). Photographs taken at early termination visit were not available for every early termination subject as some subjects refused to have their photographs taken. Thus, early termination and lost to follow-up subjects were excluded from this analysis. The total number of subjects included in the ITT analysis was 92.
Arm/Group Title Redermic - Assessor 1 Rejuva-A - Assessor 1 Combination of Redermic and Rejuva-A - Assessor 1 Redermic - Assessor 2 Rejuva-A - Assessor 2 Combination of Redermic and Rejuva-A - Assessor 2
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 29 33 30 29 33 30
Measure Type: Number
Unit of Measure: Participants
Worsening 7 4 5 5 4 1
Stable 14 19 18 19 21 23
Improvement 8 10 7 5 8 6
3.Secondary Outcome
Title Trans-epidermal Water Loss (TEWL).
Hide Description Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study.
Time Frame 12, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: g / m² / h
Week 12 10.51  (3.45) 12.33  (4.39) 13.12  (5.72)
Week 24 10.20  (3.12) 12.64  (4.47) 12.45  (6.00)
4.Secondary Outcome
Title Skin Hydration (Conductance)
Hide Description

Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe.

Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration.

Time Frame 12, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: µsiemens (µmho)
Week 12 65.10  (34.38) 84.25  (51.14) 74.85  (37.56)
Week 24 66.45  (30.48) 83.65  (47.59) 80.70  (45.80)
5.Secondary Outcome
Title Skin Elasticity.
Hide Description Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy.
Time Frame 12, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: kilo Pascals
Week 12 19.56  (11.09) 18.16  (10.65) 17.34  (7.99)
Week 24 20.30  (10.54) 17.21  (9.42) 18.30  (9.19)
6.Secondary Outcome
Title Area Ratio - Analysis of Skin Replicas of Crow's Feet.
Hide Description An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only the per protocol (PP) population was considered for this analysis. Early termination and lost subjects were excluded from this analysis. Furthermore, some replicas of subjects who completed the study could not be analyzed with precision and were consequently excluded from the analysis by the laboratory.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 21 21 28
Mean (Standard Deviation)
Unit of Measure: mm²
6.35  (5.49) 3.52  (2.99) 7.35  (6.38)
7.Secondary Outcome
Title Clinical Skin Evaluation.
Hide Description A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses.
Time Frame 12, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 29.90  (4.66) 30.35  (5.14) 29.63  (5.06)
Week 24 31.00  (4.89) 30.90  (5.51) 30.25  (4.74)
8.Secondary Outcome
Title Sensitivity of the Face Evaluated by Subject.
Hide Description

Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately.

Each score is from 0 = absent to 10 important.

Time Frame 12, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Pruritus sensation Week 12 1.13  (2.06) 1.62  (2.31) 1.95  (2.69)
Pruritus sensation Week 24 1.01  (1.77) 1.79  (2.06) 2.06  (2.78)
Tingling sensation Week 12 1.36  (2.41) 2.02  (2.50) 3.06  (3.08)
Tingling sensation Week 24 0.85  (1.44) 2.24  (2.53) 2.33  (2.98)
Burning sensation Week 12 1.34  (2.37) 2.61  (2.84) 3.55  (3.36)
Burning sensation Week 24 0.69  (1.64) 1.89  (2.59) 2.85  (3.41)
Tightness sensatioin Week 12 1.57  (2.20) 1.94  (2.21) 3.00  (3.10)
Tightness sensation Week 24 1.45  (2.00) 2.45  (2.94) 2.27  (2.56)
9.Secondary Outcome
Title Facial Skin Self-evaluation.
Hide Description A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important.
Time Frame 12, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Hydration Week 12 6.01  (2.08) 5.54  (2.02) 5.53  (2.32)
Hydration Week 24 6.80  (2.14) 6.12  (2.18) 5.93  (1.90)
Firmness Week 12 5.43  (2.12) 5.10  (2.32) 5.24  (1.91)
Firmness Week 24 5.72  (2.23) 5.60  (1.92) 5.59  (1.64)
Radiance Week 12 5.63  (1.63) 5.41  (2.12) 5.76  (1.91)
Radiance Week 24 6.11  (1.91) 5.81  (1.74) 6.07  (1.80)
Softness Week 12 6.20  (1.84) 5.53  (1.84) 5.80  (1.47)
Softness Week 24 6.40  (2.12) 5.60  (2.06) 6.18  (1.70)
Comfort Week 12 6.29  (2.16) 6.21  (1.89) 5.96  (2.16)
Comfort Week 24 7.05  (2.01) 6.20  (2.23) 6.49  (1.84)
Smoothness Week 12 6.83  (1.80) 6.88  (2.16) 6.63  (1.81)
Smoothness Week 24 7.26  (1.81) 6.98  (1.93) 6.85  (1.95)
Fine lines Week 12 5.15  (1.85) 4.82  (2.02) 5.18  (2.40)
Fine lines Week 24 5.00  (2.01) 5.03  (2.02) 4.97  (2.38)
Wrinkles Week 12 4.99  (2.07) 5.06  (2.08) 5.38  (2.27)
Wrinkles Week 24 5.43  (2.14) 5.40  (2.23) 5.23  (1.89)
Spots Week 12 3.13  (2.29) 4.32  (2.77) 4.00  (2.62)
Spots Week 24 3.22  (2.65) 4.35  (2.95) 3.57  (2.69)
Roughness Week 12 2.74  (2.05) 3.44  (2.64) 3.41  (2.32)
Roughness Week 24 2.96  (2.60) 3.09  (2.75) 3.49  (2.38)
Imperfections Week 12 4.52  (2.30) 4.39  (2.23) 4.73  (2.80)
Imperfections Week 24 4.27  (2.56) 4.82  (2.33) 4.58  (2.51)
Dryness Week 12 4.21  (2.59) 4.30  (2.71) 4.60  (2.87)
Dryness Week 24 3.72  (2.52) 4.21  (2.82) 4.66  (2.75)
Redness Week 12 3.33  (3.10) 3.94  (2.66) 3.75  (2.81)
Redness Week 24 3.16  (2.68) 3.51  (2.80) 3.96  (3.11)
10.Secondary Outcome
Title Tolerance Evaluated by Investigator.
Hide Description

Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale.

Scaling, Dryness and Erythema Evaluations

- None (0) - Very Severe = (4)

Burning and Itching Evaluation Scale

  • None (0) = Normal, no discomfort
  • Mild (1) = Slight discomfort that is not bothersome
  • Moderate (2) = Discomfort that is somewhat bothersome
  • Marked (3) = Discomfort that is bothersome and that occasionally interferes with normal daily activities
  • Severe (4) = Continuous discomfort that interferes with normal daily activities
Time Frame 12, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description:
Cream applied twice a day every day, morning and evening for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Scaling Week 12 0.10  (0.30) 0.28  (0.55) 0.15  (0.43)
Scaling Week 24 0.10  (0.30) 0.30  (0.56) 0.33  (0.66)
Dryness Week 12 0.15  (0.36) 0.30  (0.52) 0.23  (0.58)
Dryness Week 24 0.13  (0.33) 0.25  (0.49) 0.35  (0.70)
Erythema Week 12 0.15  (0.43) 0.05  (0.22) 0.10  (0.30)
Erythema Week 24 0.13  (0.33) 0.10  (0.30) 0.23  (0.48)
Burning and itching Week 12 0.03  (0.16) 0.23  (0.58) 0.23  (0.48)
Burning and itching Week 24 0.03  (0.16) 0.25  (0.67) 0.23  (0.53)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Redermic Rejuva-A Combination of Redermic and Rejuva-A
Hide Arm/Group Description Cream applied twice a day every day, morning and evening for 24 weeks. Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks. Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
All-Cause Mortality
Redermic Rejuva-A Combination of Redermic and Rejuva-A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Redermic Rejuva-A Combination of Redermic and Rejuva-A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      0/40 (0.00%)      0/40 (0.00%)    
Infections and infestations       
Appendicitis *  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Redermic Rejuva-A Combination of Redermic and Rejuva-A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/40 (7.50%)      10/40 (25.00%)      6/40 (15.00%)    
Eye disorders       
Conjunctivitis *  1/40 (2.50%)  1 2/40 (5.00%)  2 0/40 (0.00%)  0
Infections and infestations       
Common Cold *  0/40 (0.00%)  0 5/40 (12.50%)  5 2/40 (5.00%)  2
Influenza *  0/40 (0.00%)  0 2/40 (5.00%)  2 0/40 (0.00%)  0
Psychiatric disorders       
Insomnia *  2/40 (5.00%)  2 0/40 (0.00%)  0 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis *  0/40 (0.00%)  0 1/40 (2.50%)  1 4/40 (10.00%)  4
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Annie Levesque
Organization: Innovaderm Research Inc
Phone: 514-521-4285 ext 222
Responsible Party: Robert BISSONNETTE, Cosmetique Active International
ClinicalTrials.gov Identifier: NCT00974480     History of Changes
Other Study ID Numbers: LRP09008
First Submitted: July 24, 2009
First Posted: September 10, 2009
Results First Submitted: November 16, 2010
Results First Posted: December 15, 2010
Last Update Posted: September 20, 2011