Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer
Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
Participant gender:
Summary
One-third of all malignancies in the United States (approximately one million cases diagnosed
annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic
burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies
with a topical agent free of serious side effects would confer substantial public health
benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is
one of the most common conditions requiring dermatologic care in the VA system. Topical
tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in
high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have
unacceptable toxicity. In this study, 1131 patients with a recent history of squamous cell
and/or basal cell carcinoma were enrolled at six participating centers over a four-year
period and were randomly assigned to either 0.1% tretinoin cream or placebo. They were
followed for a minimum of two years to determine if topical tretinoin is effective in
reducing the risk of new occurrences.
Phase:
Phase 3
Details
Lead Sponsor:
US Department of Veterans Affairs VA Office of Research and Development