Skin Aging Clinical Trial
Official title:
Single Blind Study to Evaluate the Tolerance and Effectiveness of Redermic Versus Rejuva-A™ (0.025% Tretinoin) and Redermic in Combination With Rejuva-A™ (0.025% Tretinoin) Under Normal Conditions in Subjects With Signs of Aging
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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