The Effect of Efudex (5-Fluorouracil) Treatment on Photoaged Skin
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Actinic Keratoses resolution and improvement in photoaging
John J Voorhees, MD
University of Michigan
United States: Institutional Review Board
|University of Michigan Department of Dermatology||Ann Arbor, Michigan 48109|