Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging
Condition: Skin Aging
Study type: Interventional

Summary: 
      Facial skin aging is a complex process combining factors such as sun exposure, smoking and
      those that are believed to be inherited. Changes in the skin over time including decreased
      thickness result in skin atrophy, wrinkling, sagging, yellowness and changes in pigmentation.
      Redermic is a cosmetic cream that has been evaluated clinically but not in comparison to
      tretinoin nor in combination with tretinoin. There is no data 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.

      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).
    

Detailed description: 
      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.
    

Intervention name(s): Redermic; Tretinoin (Rejuva-A)
Intervention type(s): Other; Drug
Intervention description(s): Cosmetic cream formulation 609637 43.; Tretinoin 0.025% cream.
Other intervention name(s): madescassoside; vitamin C; Rejuva-A
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skin; Aging; Rejuva-a; Redermic