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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Skin Aging
Interventions:	Other: Redermic Drug: Tretinoin (Rejuva-A)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from September 2009 to January 2010 at a research clinic.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Redermic	Rejuva-A	Combination of Redermic and Rejuva-A
STARTED	40	40	40
COMPLETED	29	33	30
NOT COMPLETED	11	7	10

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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.

Baseline Measures

	Redermic	Rejuva-A	Combination of Redermic and Rejuva-A	Total
Number of Participants [units: participants]	40	40	40	120
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	40	40	40	120
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	49.85 ± 3.18	51.15 ± 3.20	50.53 ± 2.84	50.51 ± 3.10
Gender [units: participants]
Female	40	40	40	120
Male	0	0	0	0
Region of Enrollment [units: participants]
Canada	40	40	40	120
Skin aging measured with photonumeric scale ^[1] [units: Units on a Scale] Mean ± Standard Deviation	22.23 ± 7.10	21.88 ± 5.83	22.14 ± 5.13	22.08 ± 6.06
Transepidermal water loss (TEWL) ^[2] [units: g / m² / h] Mean ± Standard Deviation	9.90 ± 3.32	9.61 ± 2.95	9.71 ± 2.47	9.74 ± 2.91
Skin hydration (conductance) ^[3] [units: µsiemens (µmho)] Mean ± Standard Deviation	51.00 ± 25.58	64.35 ± 42.44	57.25 ± 26.54	57.53 ± 32.64
Skin elasticity ^[4] [units: kilo Pascals] Mean ± Standard Deviation	20.61 ± 10.83	19.27 ± 8.51	20.61 ± 9.75	20.16 ± 9.68
Crow's feet replicas - area ratio ^[5] [units: mm²] Mean ± Standard Deviation	7.98 ± 6.31	5.87 ± 4.78	9.28 ± 7.71	7.53 ± 5.52
Clinical skin evaluation ^[6] [units: Units on a scale] Mean ± Standard Deviation	29.05 ± 5.52	29.20 ± 5.96	28.65 ± 6.06	28.97 ± 5.81
Sensitivity of the face evaluated by subject ^[7] [units: Units on a scale] Mean ± Standard Deviation
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
Facial skin self-evaluation ^[8] [units: Units on a scale] Mean ± Standard Deviation
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
Tolerance evaluated by investigator ^[9] [units: Units on a scale] Mean ± Standard Deviation
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]	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).
[2]	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.
[3]	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.
[4]	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.
[5]	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.
[6]	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.
[7]	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.
[8]	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
[9]	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

Responsible Party:	Robert BISSONNETTE, Cosmetique Active International
ClinicalTrials.gov Identifier:	NCT00974480 History of Changes
Other Study ID Numbers:	LRP09008
Study First Received:	July 24, 2009
Results First Received:	November 16, 2010
Last Updated:	September 18, 2011
Health Authority:	Canada: Ethics Review Committee