Trial Outcomes & Findings for Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging (NCT NCT00974480)
NCT ID: NCT00974480
Last Updated: 2011-09-20
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
12, 24 weeks
Results posted on
2011-09-20
Participant Flow
Subjects were recruited from September 2009 to January 2010 at a research clinic.
Participant milestones
| Measure |
Redermic
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
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.
|
Combination of Redermic and Rejuva-A
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 Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
29
|
33
|
30
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging
Baseline characteristics by cohort
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
49.85 years
STANDARD_DEVIATION 3.18 • n=5 Participants
|
51.15 years
STANDARD_DEVIATION 3.20 • n=7 Participants
|
50.53 years
STANDARD_DEVIATION 2.84 • n=5 Participants
|
50.51 years
STANDARD_DEVIATION 3.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
40 participants
n=5 Participants
|
120 participants
n=4 Participants
|
|
Skin aging measured with photonumeric scale
|
22.23 Units on a Scale
STANDARD_DEVIATION 7.10 • n=5 Participants
|
21.88 Units on a Scale
STANDARD_DEVIATION 5.83 • n=7 Participants
|
22.14 Units on a Scale
STANDARD_DEVIATION 5.13 • n=5 Participants
|
22.08 Units on a Scale
STANDARD_DEVIATION 6.06 • n=4 Participants
|
|
Transepidermal water loss (TEWL)
|
9.90 g / m² / h
STANDARD_DEVIATION 3.32 • n=5 Participants
|
9.61 g / m² / h
STANDARD_DEVIATION 2.95 • n=7 Participants
|
9.71 g / m² / h
STANDARD_DEVIATION 2.47 • n=5 Participants
|
9.74 g / m² / h
STANDARD_DEVIATION 2.91 • n=4 Participants
|
|
Skin hydration (conductance)
|
51.00 µsiemens (µmho)
STANDARD_DEVIATION 25.58 • n=5 Participants
|
64.35 µsiemens (µmho)
STANDARD_DEVIATION 42.44 • n=7 Participants
|
57.25 µsiemens (µmho)
STANDARD_DEVIATION 26.54 • n=5 Participants
|
57.53 µsiemens (µmho)
STANDARD_DEVIATION 32.64 • n=4 Participants
|
|
Skin elasticity
|
20.61 kilo Pascals
STANDARD_DEVIATION 10.83 • n=5 Participants
|
19.27 kilo Pascals
STANDARD_DEVIATION 8.51 • n=7 Participants
|
20.61 kilo Pascals
STANDARD_DEVIATION 9.75 • n=5 Participants
|
20.16 kilo Pascals
STANDARD_DEVIATION 9.68 • n=4 Participants
|
|
Crow's feet replicas - area ratio
|
7.98 mm²
STANDARD_DEVIATION 6.31 • n=5 Participants
|
5.87 mm²
STANDARD_DEVIATION 4.78 • n=7 Participants
|
9.28 mm²
STANDARD_DEVIATION 7.71 • n=5 Participants
|
7.53 mm²
STANDARD_DEVIATION 5.52 • n=4 Participants
|
|
Clinical skin evaluation
|
29.05 Units on a scale
STANDARD_DEVIATION 5.52 • n=5 Participants
|
29.20 Units on a scale
STANDARD_DEVIATION 5.96 • n=7 Participants
|
28.65 Units on a scale
STANDARD_DEVIATION 6.06 • n=5 Participants
|
28.97 Units on a scale
STANDARD_DEVIATION 5.81 • n=4 Participants
|
|
Sensitivity of the face evaluated by subject
Pruritus
|
0.94 Units on a scale
STANDARD_DEVIATION 1.51 • n=5 Participants
|
1.01 Units on a scale
STANDARD_DEVIATION 1.88 • n=7 Participants
|
0.65 Units on a scale
STANDARD_DEVIATION 1.73 • n=5 Participants
|
0.87 Units on a scale
STANDARD_DEVIATION 1.71 • n=4 Participants
|
|
Sensitivity of the face evaluated by subject
Tingling
|
0.99 Units on a scale
STANDARD_DEVIATION 1.51 • n=5 Participants
|
0.69 Units on a scale
STANDARD_DEVIATION 1.28 • n=7 Participants
|
1.04 Units on a scale
STANDARD_DEVIATION 1.77 • n=5 Participants
|
0.91 Units on a scale
STANDARD_DEVIATION 1.53 • n=4 Participants
|
|
Sensitivity of the face evaluated by subject
Burning
|
0.83 Units on a scale
STANDARD_DEVIATION 1.67 • n=5 Participants
|
0.55 Units on a scale
STANDARD_DEVIATION 1.27 • n=7 Participants
|
0.45 Units on a scale
STANDARD_DEVIATION 1.19 • n=5 Participants
|
0.61 Units on a scale
STANDARD_DEVIATION 1.39 • n=4 Participants
|
|
Sensitivity of the face evaluated by subject
Tightness
|
1.56 Units on a scale
STANDARD_DEVIATION 2.02 • n=5 Participants
|
1.62 Units on a scale
STANDARD_DEVIATION 2.21 • n=7 Participants
|
1.30 Units on a scale
STANDARD_DEVIATION 2.47 • n=5 Participants
|
1.49 Units on a scale
STANDARD_DEVIATION 2.23 • n=4 Participants
|
|
Facial skin self-evaluation
Hydration
|
4.65 Units on a scale
STANDARD_DEVIATION 2.01 • n=5 Participants
|
4.61 Units on a scale
STANDARD_DEVIATION 1.81 • n=7 Participants
|
4.98 Units on a scale
STANDARD_DEVIATION 1.55 • n=5 Participants
|
4.75 Units on a scale
STANDARD_DEVIATION 1.79 • n=4 Participants
|
|
Facial skin self-evaluation
Firmness
|
4.67 Units on a scale
STANDARD_DEVIATION 2.00 • n=5 Participants
|
5.34 Units on a scale
STANDARD_DEVIATION 2.27 • n=7 Participants
|
4.62 Units on a scale
STANDARD_DEVIATION 1.60 • n=5 Participants
|
4.88 Units on a scale
STANDARD_DEVIATION 1.99 • n=4 Participants
|
|
Facial skin self-evaluation
Radiance
|
5.14 Units on a scale
STANDARD_DEVIATION 1.72 • n=5 Participants
|
4.86 Units on a scale
STANDARD_DEVIATION 1.69 • n=7 Participants
|
5.01 Units on a scale
STANDARD_DEVIATION 2.10 • n=5 Participants
|
5.00 Units on a scale
STANDARD_DEVIATION 1.83 • n=4 Participants
|
|
Facial skin self-evaluation
Softness
|
5.54 Units on a scale
STANDARD_DEVIATION 1.54 • n=5 Participants
|
5.10 Units on a scale
STANDARD_DEVIATION 2.19 • n=7 Participants
|
5.24 Units on a scale
STANDARD_DEVIATION 1.93 • n=5 Participants
|
5.29 Units on a scale
STANDARD_DEVIATION 1.90 • n=4 Participants
|
|
Facial skin self-evaluation
Comfort
|
5.39 Units on a scale
STANDARD_DEVIATION 1.97 • n=5 Participants
|
5.75 Units on a scale
STANDARD_DEVIATION 1.93 • n=7 Participants
|
6.31 Units on a scale
STANDARD_DEVIATION 2.48 • n=5 Participants
|
5.82 Units on a scale
STANDARD_DEVIATION 2.16 • n=4 Participants
|
|
Facial skin self-evaluation
Smoothness
|
6.20 Units on a scale
STANDARD_DEVIATION 2.02 • n=5 Participants
|
6.53 Units on a scale
STANDARD_DEVIATION 2.25 • n=7 Participants
|
6.51 Units on a scale
STANDARD_DEVIATION 1.95 • n=5 Participants
|
6.41 Units on a scale
STANDARD_DEVIATION 2.07 • n=4 Participants
|
|
Facial skin self-evaluation
Fine Lines
|
5.06 Units on a scale
STANDARD_DEVIATION 1.85 • n=5 Participants
|
5.52 Units on a scale
STANDARD_DEVIATION 2.12 • n=7 Participants
|
5.11 Units on a scale
STANDARD_DEVIATION 2.12 • n=5 Participants
|
5.23 Units on a scale
STANDARD_DEVIATION 2.03 • n=4 Participants
|
|
Facial skin self-evaluation
Wrinkles
|
5.14 Units on a scale
STANDARD_DEVIATION 2.14 • n=5 Participants
|
5.67 Units on a scale
STANDARD_DEVIATION 2.15 • n=7 Participants
|
5.06 Units on a scale
STANDARD_DEVIATION 2.17 • n=5 Participants
|
5.29 Units on a scale
STANDARD_DEVIATION 2.15 • n=4 Participants
|
|
Facial skin self-evaluation
Spots
|
2.92 Units on a scale
STANDARD_DEVIATION 2.31 • n=5 Participants
|
3.97 Units on a scale
STANDARD_DEVIATION 2.60 • n=7 Participants
|
4.17 Units on a scale
STANDARD_DEVIATION 2.81 • n=5 Participants
|
3.68 Units on a scale
STANDARD_DEVIATION 2.62 • n=4 Participants
|
|
Facial skin self-evaluation
Roughness
|
2.65 Units on a scale
STANDARD_DEVIATION 2.14 • n=5 Participants
|
3.02 Units on a scale
STANDARD_DEVIATION 2.62 • n=7 Participants
|
2.50 Units on a scale
STANDARD_DEVIATION 2.14 • n=5 Participants
|
2.72 Units on a scale
STANDARD_DEVIATION 2.31 • n=4 Participants
|
|
Facial skin self-evaluation
Imperfections
|
4.73 Units on a scale
STANDARD_DEVIATION 2.41 • n=5 Participants
|
5.08 Units on a scale
STANDARD_DEVIATION 2.18 • n=7 Participants
|
5.24 Units on a scale
STANDARD_DEVIATION 2.57 • n=5 Participants
|
5.01 Units on a scale
STANDARD_DEVIATION 2.38 • n=4 Participants
|
|
Facial skin self-evaluation
Dryness
|
5.01 Units on a scale
STANDARD_DEVIATION 2.32 • n=5 Participants
|
5.15 Units on a scale
STANDARD_DEVIATION 2.34 • n=7 Participants
|
4.35 Units on a scale
STANDARD_DEVIATION 2.65 • n=5 Participants
|
4.83 Units on a scale
STANDARD_DEVIATION 2.45 • n=4 Participants
|
|
Facial skin self-evaluation
Redness
|
3.04 Units on a scale
STANDARD_DEVIATION 2.65 • n=5 Participants
|
3.00 Units on a scale
STANDARD_DEVIATION 3.09 • n=7 Participants
|
2.92 Units on a scale
STANDARD_DEVIATION 3.00 • n=5 Participants
|
2.99 Units on a scale
STANDARD_DEVIATION 2.89 • n=4 Participants
|
|
Tolerance evaluated by investigator
Scaling
|
0.08 Units on a scale
STANDARD_DEVIATION 0.27 • n=5 Participants
|
0.05 Units on a scale
STANDARD_DEVIATION 0.22 • n=7 Participants
|
0.03 Units on a scale
STANDARD_DEVIATION 0.16 • n=5 Participants
|
0.05 Units on a scale
STANDARD_DEVIATION 0.22 • n=4 Participants
|
|
Tolerance evaluated by investigator
Dryness
|
0.13 Units on a scale
STANDARD_DEVIATION 0.33 • n=5 Participants
|
0.10 Units on a scale
STANDARD_DEVIATION 0.30 • n=7 Participants
|
0.15 Units on a scale
STANDARD_DEVIATION 0.36 • n=5 Participants
|
0.13 Units on a scale
STANDARD_DEVIATION 0.33 • n=4 Participants
|
|
Tolerance evaluated by investigator
Erythema
|
0.05 Units on a scale
STANDARD_DEVIATION 0.32 • n=5 Participants
|
0.0 Units on a scale
STANDARD_DEVIATION 0.0 • n=7 Participants
|
0.08 Units on a scale
STANDARD_DEVIATION 0.27 • n=5 Participants
|
0.04 Units on a scale
STANDARD_DEVIATION 0.24 • n=4 Participants
|
|
Tolerance evaluated by investigator
Burning and itching
|
0.13 Units on a scale
STANDARD_DEVIATION 0.33 • n=5 Participants
|
0.18 Units on a scale
STANDARD_DEVIATION 0.59 • n=7 Participants
|
0.08 Units on a scale
STANDARD_DEVIATION 0.27 • n=5 Participants
|
0.13 Units on a scale
STANDARD_DEVIATION 0.42 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12, 24 weeksPopulation: Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
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).
Outcome measures
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Skin Aging Measured With the Photonumeric Scale.
Week 24
|
21.03 Units on a scale
Standard Deviation 6.81
|
20.92 Units on a scale
Standard Deviation 5.75
|
21.31 Units on a scale
Standard Deviation 5.26
|
—
|
—
|
—
|
|
Skin Aging Measured With the Photonumeric Scale.
Week 12
|
21.25 Units on a scale
Standard Deviation 6.60
|
21.36 Units on a scale
Standard Deviation 5.93
|
21.21 Units on a scale
Standard Deviation 5.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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.
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".
Outcome measures
| Measure |
Redermic
n=29 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=33 Participants
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.
|
Combination of Redermic and Rejuva-A
n=30 Participants
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.
|
Redermic - Assessor 2
n=29 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
n=33 Participants
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
n=30 Participants
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.
|
|---|---|---|---|---|---|---|
|
Photographic Evaluation by a Panel of Blinded Dermatologists.
Worsening
|
7 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Photographic Evaluation by a Panel of Blinded Dermatologists.
Stable
|
14 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
21 Participants
|
23 Participants
|
|
Photographic Evaluation by a Panel of Blinded Dermatologists.
Improvement
|
8 Participants
|
10 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12, 24 weeksPopulation: Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
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.
Outcome measures
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Trans-epidermal Water Loss (TEWL).
Week 12
|
10.51 g / m² / h
Standard Deviation 3.45
|
12.33 g / m² / h
Standard Deviation 4.39
|
13.12 g / m² / h
Standard Deviation 5.72
|
—
|
—
|
—
|
|
Trans-epidermal Water Loss (TEWL).
Week 24
|
10.20 g / m² / h
Standard Deviation 3.12
|
12.64 g / m² / h
Standard Deviation 4.47
|
12.45 g / m² / h
Standard Deviation 6.00
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12, 24 weeksPopulation: Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
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.
Outcome measures
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Skin Hydration (Conductance)
Week 12
|
65.10 µsiemens (µmho)
Standard Deviation 34.38
|
84.25 µsiemens (µmho)
Standard Deviation 51.14
|
74.85 µsiemens (µmho)
Standard Deviation 37.56
|
—
|
—
|
—
|
|
Skin Hydration (Conductance)
Week 24
|
66.45 µsiemens (µmho)
Standard Deviation 30.48
|
83.65 µsiemens (µmho)
Standard Deviation 47.59
|
80.70 µsiemens (µmho)
Standard Deviation 45.80
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12, 24 weeksPopulation: Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
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.
Outcome measures
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Skin Elasticity.
Week 12
|
19.56 kilo Pascals
Standard Deviation 11.09
|
18.16 kilo Pascals
Standard Deviation 10.65
|
17.34 kilo Pascals
Standard Deviation 7.99
|
—
|
—
|
—
|
|
Skin Elasticity.
Week 24
|
20.30 kilo Pascals
Standard Deviation 10.54
|
17.21 kilo Pascals
Standard Deviation 9.42
|
18.30 kilo Pascals
Standard Deviation 9.19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Redermic
n=21 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=21 Participants
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.
|
Combination of Redermic and Rejuva-A
n=28 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Area Ratio - Analysis of Skin Replicas of Crow's Feet.
|
6.35 mm²
Standard Deviation 5.49
|
3.52 mm²
Standard Deviation 2.99
|
7.35 mm²
Standard Deviation 6.38
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12, 24 weeksPopulation: Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
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.
Outcome measures
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Clinical Skin Evaluation.
Week 12
|
29.90 Units on a scale
Standard Deviation 4.66
|
30.35 Units on a scale
Standard Deviation 5.14
|
29.63 Units on a scale
Standard Deviation 5.06
|
—
|
—
|
—
|
|
Clinical Skin Evaluation.
Week 24
|
31.00 Units on a scale
Standard Deviation 4.89
|
30.90 Units on a scale
Standard Deviation 5.51
|
30.25 Units on a scale
Standard Deviation 4.74
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12, 24 weeksPopulation: Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
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.
Outcome measures
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Sensitivity of the Face Evaluated by Subject.
Pruritus sensation Week 12
|
1.13 Units on a scale
Standard Deviation 2.06
|
1.62 Units on a scale
Standard Deviation 2.31
|
1.95 Units on a scale
Standard Deviation 2.69
|
—
|
—
|
—
|
|
Sensitivity of the Face Evaluated by Subject.
Pruritus sensation Week 24
|
1.01 Units on a scale
Standard Deviation 1.77
|
1.79 Units on a scale
Standard Deviation 2.06
|
2.06 Units on a scale
Standard Deviation 2.78
|
—
|
—
|
—
|
|
Sensitivity of the Face Evaluated by Subject.
Tingling sensation Week 12
|
1.36 Units on a scale
Standard Deviation 2.41
|
2.02 Units on a scale
Standard Deviation 2.50
|
3.06 Units on a scale
Standard Deviation 3.08
|
—
|
—
|
—
|
|
Sensitivity of the Face Evaluated by Subject.
Tingling sensation Week 24
|
0.85 Units on a scale
Standard Deviation 1.44
|
2.24 Units on a scale
Standard Deviation 2.53
|
2.33 Units on a scale
Standard Deviation 2.98
|
—
|
—
|
—
|
|
Sensitivity of the Face Evaluated by Subject.
Burning sensation Week 12
|
1.34 Units on a scale
Standard Deviation 2.37
|
2.61 Units on a scale
Standard Deviation 2.84
|
3.55 Units on a scale
Standard Deviation 3.36
|
—
|
—
|
—
|
|
Sensitivity of the Face Evaluated by Subject.
Burning sensation Week 24
|
0.69 Units on a scale
Standard Deviation 1.64
|
1.89 Units on a scale
Standard Deviation 2.59
|
2.85 Units on a scale
Standard Deviation 3.41
|
—
|
—
|
—
|
|
Sensitivity of the Face Evaluated by Subject.
Tightness sensatioin Week 12
|
1.57 Units on a scale
Standard Deviation 2.20
|
1.94 Units on a scale
Standard Deviation 2.21
|
3.00 Units on a scale
Standard Deviation 3.10
|
—
|
—
|
—
|
|
Sensitivity of the Face Evaluated by Subject.
Tightness sensation Week 24
|
1.45 Units on a scale
Standard Deviation 2.00
|
2.45 Units on a scale
Standard Deviation 2.94
|
2.27 Units on a scale
Standard Deviation 2.56
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12, 24 weeksPopulation: Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
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.
Outcome measures
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Facial Skin Self-evaluation.
Redness Week 12
|
3.33 Units on a scale
Standard Deviation 3.10
|
3.94 Units on a scale
Standard Deviation 2.66
|
3.75 Units on a scale
Standard Deviation 2.81
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Hydration Week 12
|
6.01 Units on a scale
Standard Deviation 2.08
|
5.54 Units on a scale
Standard Deviation 2.02
|
5.53 Units on a scale
Standard Deviation 2.32
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Hydration Week 24
|
6.80 Units on a scale
Standard Deviation 2.14
|
6.12 Units on a scale
Standard Deviation 2.18
|
5.93 Units on a scale
Standard Deviation 1.90
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Firmness Week 12
|
5.43 Units on a scale
Standard Deviation 2.12
|
5.10 Units on a scale
Standard Deviation 2.32
|
5.24 Units on a scale
Standard Deviation 1.91
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Firmness Week 24
|
5.72 Units on a scale
Standard Deviation 2.23
|
5.60 Units on a scale
Standard Deviation 1.92
|
5.59 Units on a scale
Standard Deviation 1.64
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Radiance Week 12
|
5.63 Units on a scale
Standard Deviation 1.63
|
5.41 Units on a scale
Standard Deviation 2.12
|
5.76 Units on a scale
Standard Deviation 1.91
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Radiance Week 24
|
6.11 Units on a scale
Standard Deviation 1.91
|
5.81 Units on a scale
Standard Deviation 1.74
|
6.07 Units on a scale
Standard Deviation 1.80
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Softness Week 12
|
6.20 Units on a scale
Standard Deviation 1.84
|
5.53 Units on a scale
Standard Deviation 1.84
|
5.80 Units on a scale
Standard Deviation 1.47
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Softness Week 24
|
6.40 Units on a scale
Standard Deviation 2.12
|
5.60 Units on a scale
Standard Deviation 2.06
|
6.18 Units on a scale
Standard Deviation 1.70
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Comfort Week 12
|
6.29 Units on a scale
Standard Deviation 2.16
|
6.21 Units on a scale
Standard Deviation 1.89
|
5.96 Units on a scale
Standard Deviation 2.16
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Comfort Week 24
|
7.05 Units on a scale
Standard Deviation 2.01
|
6.20 Units on a scale
Standard Deviation 2.23
|
6.49 Units on a scale
Standard Deviation 1.84
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Smoothness Week 12
|
6.83 Units on a scale
Standard Deviation 1.80
|
6.88 Units on a scale
Standard Deviation 2.16
|
6.63 Units on a scale
Standard Deviation 1.81
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Smoothness Week 24
|
7.26 Units on a scale
Standard Deviation 1.81
|
6.98 Units on a scale
Standard Deviation 1.93
|
6.85 Units on a scale
Standard Deviation 1.95
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Fine lines Week 12
|
5.15 Units on a scale
Standard Deviation 1.85
|
4.82 Units on a scale
Standard Deviation 2.02
|
5.18 Units on a scale
Standard Deviation 2.40
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Fine lines Week 24
|
5.00 Units on a scale
Standard Deviation 2.01
|
5.03 Units on a scale
Standard Deviation 2.02
|
4.97 Units on a scale
Standard Deviation 2.38
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Wrinkles Week 12
|
4.99 Units on a scale
Standard Deviation 2.07
|
5.06 Units on a scale
Standard Deviation 2.08
|
5.38 Units on a scale
Standard Deviation 2.27
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Wrinkles Week 24
|
5.43 Units on a scale
Standard Deviation 2.14
|
5.40 Units on a scale
Standard Deviation 2.23
|
5.23 Units on a scale
Standard Deviation 1.89
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Spots Week 12
|
3.13 Units on a scale
Standard Deviation 2.29
|
4.32 Units on a scale
Standard Deviation 2.77
|
4.00 Units on a scale
Standard Deviation 2.62
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Spots Week 24
|
3.22 Units on a scale
Standard Deviation 2.65
|
4.35 Units on a scale
Standard Deviation 2.95
|
3.57 Units on a scale
Standard Deviation 2.69
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Roughness Week 12
|
2.74 Units on a scale
Standard Deviation 2.05
|
3.44 Units on a scale
Standard Deviation 2.64
|
3.41 Units on a scale
Standard Deviation 2.32
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Roughness Week 24
|
2.96 Units on a scale
Standard Deviation 2.60
|
3.09 Units on a scale
Standard Deviation 2.75
|
3.49 Units on a scale
Standard Deviation 2.38
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Imperfections Week 12
|
4.52 Units on a scale
Standard Deviation 2.30
|
4.39 Units on a scale
Standard Deviation 2.23
|
4.73 Units on a scale
Standard Deviation 2.80
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Imperfections Week 24
|
4.27 Units on a scale
Standard Deviation 2.56
|
4.82 Units on a scale
Standard Deviation 2.33
|
4.58 Units on a scale
Standard Deviation 2.51
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Dryness Week 12
|
4.21 Units on a scale
Standard Deviation 2.59
|
4.30 Units on a scale
Standard Deviation 2.71
|
4.60 Units on a scale
Standard Deviation 2.87
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Dryness Week 24
|
3.72 Units on a scale
Standard Deviation 2.52
|
4.21 Units on a scale
Standard Deviation 2.82
|
4.66 Units on a scale
Standard Deviation 2.75
|
—
|
—
|
—
|
|
Facial Skin Self-evaluation.
Redness Week 24
|
3.16 Units on a scale
Standard Deviation 2.68
|
3.51 Units on a scale
Standard Deviation 2.80
|
3.96 Units on a scale
Standard Deviation 3.11
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12, 24 weeksPopulation: Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.
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
Outcome measures
| Measure |
Redermic
n=40 Participants
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 Participants
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.
|
Combination of Redermic and Rejuva-A
n=40 Participants
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.
|
Redermic - Assessor 2
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A - Assessor 2
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.
|
Combination of Redermic and Rejuva-A - Assessor 2
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.
|
|---|---|---|---|---|---|---|
|
Tolerance Evaluated by Investigator.
Scaling Week 12
|
0.10 Units on a scale
Standard Deviation 0.30
|
0.28 Units on a scale
Standard Deviation 0.55
|
0.15 Units on a scale
Standard Deviation 0.43
|
—
|
—
|
—
|
|
Tolerance Evaluated by Investigator.
Scaling Week 24
|
0.10 Units on a scale
Standard Deviation 0.30
|
0.30 Units on a scale
Standard Deviation 0.56
|
0.33 Units on a scale
Standard Deviation 0.66
|
—
|
—
|
—
|
|
Tolerance Evaluated by Investigator.
Dryness Week 12
|
0.15 Units on a scale
Standard Deviation 0.36
|
0.30 Units on a scale
Standard Deviation 0.52
|
0.23 Units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
|
Tolerance Evaluated by Investigator.
Dryness Week 24
|
0.13 Units on a scale
Standard Deviation 0.33
|
0.25 Units on a scale
Standard Deviation 0.49
|
0.35 Units on a scale
Standard Deviation 0.70
|
—
|
—
|
—
|
|
Tolerance Evaluated by Investigator.
Erythema Week 12
|
0.15 Units on a scale
Standard Deviation 0.43
|
0.05 Units on a scale
Standard Deviation 0.22
|
0.10 Units on a scale
Standard Deviation 0.30
|
—
|
—
|
—
|
|
Tolerance Evaluated by Investigator.
Erythema Week 24
|
0.13 Units on a scale
Standard Deviation 0.33
|
0.10 Units on a scale
Standard Deviation 0.30
|
0.23 Units on a scale
Standard Deviation 0.48
|
—
|
—
|
—
|
|
Tolerance Evaluated by Investigator.
Burning and itching Week 12
|
0.03 Units on a scale
Standard Deviation 0.16
|
0.23 Units on a scale
Standard Deviation 0.58
|
0.23 Units on a scale
Standard Deviation 0.48
|
—
|
—
|
—
|
|
Tolerance Evaluated by Investigator.
Burning and itching Week 24
|
0.03 Units on a scale
Standard Deviation 0.16
|
0.25 Units on a scale
Standard Deviation 0.67
|
0.23 Units on a scale
Standard Deviation 0.53
|
—
|
—
|
—
|
Adverse Events
Redermic
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Rejuva-A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Combination of Redermic and Rejuva-A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Redermic
n=40 participants at risk
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 participants at risk
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.
|
Combination of Redermic and Rejuva-A
n=40 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
0.00%
0/40
|
Other adverse events
| Measure |
Redermic
n=40 participants at risk
Cream applied twice a day every day, morning and evening for 24 weeks.
|
Rejuva-A
n=40 participants at risk
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.
|
Combination of Redermic and Rejuva-A
n=40 participants at risk
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.
|
|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
2.5%
1/40 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Infections and infestations
Common Cold
|
0.00%
0/40
|
12.5%
5/40 • Number of events 5
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
10.0%
4/40 • Number of events 4
|
|
Infections and infestations
Influenza
|
0.00%
0/40
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place