The Effect of Efudex Treatment on Photoaged Skin
|ClinicalTrials.gov Identifier: NCT00121511|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : May 27, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Photo-aging Keratosis||Drug: Efudex (5-fluorouracil)||Not Applicable|
Efudex (5-fluorouracil) has been used as topical chemotherapy for the treatment of actinic keratoses (AKs) since the 1950's. Through many years of use, Efudex has been deemed to be a safe and effective therapy. It requires, however, a high level of patient compliance and is known to cause a vigorous inflammatory reaction when actinic keratoses are treated. It has the distinct advantage of identifying precancerous skin lesions not apparent on clinical inspection or palpation. Following a course of Efudex to the face, patients have been noted to have fewer signs of dermatoheliosis.
The investigators propose to determine if Efudex is associated with improvement of aging skin in the setting of treating actinic keratoses. The researchers hope to demonstrate less p53 staining following Efudex treatment. It is proposed that the skin improvements seen following a course of Efudex are due to both reduction of actinic keratoses and impact on photoaging. The researchers propose to quantify the effects of Efudex therapy on the immunohistochemical staining properties of facial skin with respect to p53 and procollagen. The hypothesis is that Efudex therapy will decrease p53 immunostaining thus providing biochemical evidence to support this treatment in the reduction of actinic keratoses with concomitant improvement of aging skin.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Efudex (5-fluorouracil) Treatment on Photoaged Skin|
|Study Start Date :||July 2005|
|Actual Study Completion Date :||July 2007|
- Actinic Keratoses resolution and improvement in photoaging
- Changes in p53 immunostaining intensity will be used to assess response
- Collagen production will be evaluated by Western blotting, immunohistology, and RT-PCR
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121511
|United States, Michigan|
|University of Michigan Department of Dermatology|
|Ann Arbor, Michigan, United States, 48109|
|Study Chair:||John J Voorhees, MD||University of Michigan|