Skin Aging Clinical Trial
Official title:
Topical Vitamin A (All-trans Retinol) Versus Vehicle Cream in the Treatment of Aged Skin
Verified date | September 2006 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objectives of this study are to evaluate the safety and efficacy of 0.5% retinol (Vitamin A) versus it's vehicle cream in the treatment and prevention of skin aging and Bateman's Purpura (bruising).
Status | Completed |
Enrollment | 50 |
Est. completion date | February 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - Male and female - 70 years of age or older - history of Bateman's purpura on arms - Relatively good general health and able to perform daily tasks Exclusion Criteria: - Sensitivity to any formulation ingredients - History of Cardiovascular disease with continuing deficits (example: partial paralysis) - Participated in any clinical trials within last 30 days - Topical steroids or other drugs two weeks prior to study entry (short-term application of topical antimicrobials is allowed) - Hormone replacement therapy within last 6 months. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surface Roughness | |||
Primary | Fine wrinkles | |||
Primary | Hyperpigmentation | |||
Primary | Purpura | |||
Secondary | Collagen content of skin biopsies | |||
Secondary | Glycosaminoglycan expression | |||
Secondary | CRABP-II expression |
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