N/A
N=120
Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging
Skin Aging
Bottom Line
View on ClinicalTrials.gov: NCT00974480 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Dec 2010
Primary outcome: Primary: Skin Aging Measured With the Photonumeric Scale. — 21.25; 21.36; 21.21; 21.03 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Redermic (Other); Tretinoin (Rejuva-A) (Drug)
- Age
- Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Cosmetique Active International
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Aging Measured With the Photonumeric Scale. |
21.25; 21.36; 21.21; 21.03; 20.92; 21.31 | — |
| SECONDARY Photographic Evaluation by a Panel of Blinded Dermatologists. |
7; 4; 5; 5; 4; 1 | — |
| SECONDARY Trans-epidermal Water Loss (TEWL). |
10.51; 12.33; 13.12; 10.20; 12.64; 12.45 | — |
| SECONDARY Skin Hydration (Conductance) |
65.10; 84.25; 74.85; 66.45; 83.65; 80.70 | — |
| SECONDARY Skin Elasticity. |
19.56; 18.16; 17.34; 20.30; 17.21; 18.30 | — |
| SECONDARY Area Ratio - Analysis of Skin Replicas of Crow's Feet. |
6.35; 3.52; 7.35 | — |
| SECONDARY Clinical Skin Evaluation. |
29.90; 30.35; 29.63; 31.00; 30.90; 30.25 | — |
| SECONDARY Sensitivity of the Face Evaluated by Subject. |
1.13; 1.62; 1.95; 1.01; 1.79; 2.06 | — |
| SECONDARY Facial Skin Self-evaluation. |
6.01; 5.54; 5.53; 6.80; 6.12; 5.93 | — |
| SECONDARY Tolerance Evaluated by Investigator. |
0.10; 0.28; 0.15; 0.10; 0.30; 0.33 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Subjects are female, between 45 and 55 years of age.
- Females of childbearing potential have had a negative urine pregnancy test prior to randomization.
- Subjects are willing to use adequate contraceptive method or are surgically sterile (including tubal ligation), post-menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; intra-uterine device (IUD) in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0 or oral contraceptive in use for at least 30 days before Day 0.
- Subjects are willing to avoid prolonged exposure to UV radiation for the duration of the study.
- Subjects are capable of giving written informed consent.
- Subjects have changes associated with facial skin aging/photodamaged skin.
Exclusion Criteria
- Subjects are male.
- Subjects are pregnant or lactating.
- Subjects have a known allergy to Redermic, Rejuva-A™ or to any component of the tested products.
- Subjects have made use of tretinoin, adapalene, tazarotene or other topical medications for the treatment of facial skin aging during the 12 weeks preceding Day 0.
- Subjects have applied topical alpha hydroxyl acids within 28 days of Day 0.
- Subjects have used or plan to use systemic corticosteroids within 28 days of Day 0 or during the study.
- Subjects have made use of a non-medication topical product directed at improving skin aging during the 28 days preceding Day 0.
- Subjects have a hypersensitivity to any retinoids.
- Subjects have a history of alcohol or drug abuse in the past year.
- Subjects are participating in another interventional study.
- Subjects have had a previous intense pulsed light treatment to the face.
- Subjects have had a previous laser treatment to the face directed at improving skin aging.
- Subjects have the presence of skin diseases such as psoriasis or dermatitis on the face that could interfere with study evaluations.
- Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sun tanning salons, vacations in a sunny climate or outdoor worker).
- Subjects have had a botulinum toxin A injection treatment on the face within 2 years of Day 0 or plan to receive this treatment during the study.
- Subjects have had a filler injection (collagen, hyaluronic acid, etc..) on the face within 2 years of Day 0 or plan to receive this treatment during the study.
Data sourced from ClinicalTrials.gov (NCT00974480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.