• Skin Aging Measured With the Photonumeric Scale. [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]
  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).
  
  

• Photographic Evaluation by a Panel of Blinded Dermatologists. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

  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".

  
  
• Trans-epidermal Water Loss (TEWL). [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]
  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) [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]

  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. [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]
  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.
  
  
• Area Ratio - Analysis of Skin Replicas of Crow's Feet. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  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. [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]
  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. [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]

  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. [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: No ]
  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. [ Time Frame: 12, 24 weeks ] [ Designated as safety issue: Yes ]

  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
  
  

Facial skin aging is a complex and multifactorial process combining extrinsic and intrinsic factors. Major extrinsic factors include sun exposure and smoking while intrinsic factors are believed to be genetically programmed.

Changes in the dermis are responsible for many of the important clinical changes associated with skin aging. With age there is a decrease in the number of fibroblasts and a decrease in their ability to synthesize collagen which results in a decrease in collagen I and II. This is coupled with an increase in matrix metalloproteinases activity. Skin biopsies from elderly volunteers show changes in collagen bundles which become fragmented and disorganized as well as in elastin fibers which are decreased. Changes also occur in the epidermis including a decrease in epidermal thickness and a change in the morphology of keratinocytes of the basal layer. Clinically these changes result in skin atrophy, increased skin laxity, wrinkling, sagging, yellowness and changes in pigmentation.

Redermic is a cosmetic cream containing vitamin C and madecassoside. A preliminary 20 subject split face study has shown that this product was well tolerated and could improve signs of skin aging. To evaluate changes in skin aging this study used a clinical evaluation of the face, skin hydration, the fringe technique, skin biopsies and skin elasticity measurements. The investigators did not perform transepidermal water loss (TEWL), facial skin evaluation using a photonumeric guideline, evaluation of photoaging by panel of blinded dermatologists or skin replica evaluations. There is no data on the combination of Redermic with tretinoin or on the safety and efficacy of Redermic as compared to topical tretinoin.

Rejuva is a cream currently approved by Health Canada for the treatment of photodamaged skin. It contains 0.025% tretinoin one of the most widely studied topical product for skin aging. Studies have shown that topical tretinoin increases collagen synthesis and epidermal thickness thereby improving the appearance of skin aging. The efficacy of Rejuva combined with another topical cosmetic cream such as Redermic in the treatment of skin aging is unknown.

The main objective of this single-blind study was to assess efficacy of the anti aging effect and the tolerance of Redermic alone compared to Rejuva-A™ (0.025% tretinoin) alone or in combination with Rejuva-A™ (0.025% tretinoin).

One hundred and twenty (120) subjects with signs of skin aging participated in this single-blind study to evaluate the efficacy and tolerance of Redermic versus Rejuva-A™ (0.025% tretinoin) and Redermic in combination with Rejuva-A™ (0.025% tretinoin). Subjects were randomized (1:1:1) in three groups of forty (40), and were asked to apply study product to the face (except to eyelids, nostrils and other mucous membranes) for 24 weeks.