Keratosis Clinical Trial
Official title:
The Effect of Efudex (5-fluorouracil) Treatment on Photoaged Skin
Verified date | May 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The researchers propose that skin improvements may be seen following a course of Efudex,
(5-fluorouracil), a FDA-approved topical therapy (applied directly to the skin). These
improvements could be the result of both a reduction of actinic keratoses (small red horny
growths or flesh-colored wartlike growths caused by overexposure to ultraviolet radiation or
the sun) and improvement of sun-damaged skin.
In addition, this research study is being done to determine if the expression of p53, a
tumor suppressor gene (its activity stops the formation of tumors), is decreased following
Efudex treatment. Mutations (abnormal changes) in the gene, called p53, are associated with
a certain type of skin cancer. In addition, p53-mutated genes are known to exist in
non-cancerous sun-damaged skin. Thus, the presence of p53 mutations may serve as a marker
for both sun damage and an elevated risk of developing skin cancer.
Status | Completed |
Enrollment | 21 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Age 50 or older of either gender. - Patients must have actinic keratoses - Patients must have clinical photoaging judged by rhytides, dyspigmentation, poikiloderma, lentigines, skin thinning, and/or telangiectases. - Subjects must be in generally good health and willing to undergo skin biopsies from the face. - Subjects must be willing and able to comply with the requirements of the protocol. - You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study. Exclusion Criteria: - Oral retinoid therapy (such as Accutane) within two months of study entry. - Topical retinoid, imiquimod, or diclofenac therapy within 2 months of study entry. - Prior laser re-surfacing, chemical peels for actinic keratoses or aging skin. - Pregnant or nursing subjects. - Non-compliant subjects. - Subjects with a significant medical history or concurrent illness that the investigator feels is not safe for study participation. - Prior systemic treatment with 5-fluorouracil. - Known history of allergy to lidocaine (numbing medication), 5-fluoruracil, or any other known components of Efudex. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Department of Dermatology | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Valeant Pharmaceuticals International, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Actinic Keratoses resolution and improvement in photoaging | |||
Secondary | Changes in p53 immunostaining intensity will be used to assess response | |||
Secondary | Collagen production will be evaluated by Western blotting, immunohistology, and RT-PCR |
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