Trial Information

CSP #402 - VA Topical Tretinoin Chemoprevention Trial

Primary Hypothesis: To determine the efficacy of topical tretinoin cream for the
prevention of nonmelanoma skin cancer (NMSC) among high risk individuals (at least 2 NMSC?S
in last 5 years).

Secondary Hypothesis: Secondary objectives are: (a) to determine the long-term effect of
topical tretinoin on the prevalence of premalignant actinic keratoses, and (b) to
distinguish subpopulations in which topical tretinoin is particularly effective or
ineffective, compared to the overall study population.

Intervention: Apply Tretinoin 0.1% cream or placebo cream to face and ears twice a day.

Primary Outcomes: New NMSC lesions on the face and ears. Number of actinic keratoses on
the face and ears.

Study Abstract: 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, 1200 patients with a recent history of
squamous cell and/or basal cell carcinoma will be enrolled at six participating centers over
a four-year period and will be randomly assigned to either 0.1% tretinoin cream or placebo.
They will be followed for a minimum of two years to determine if topical tretinoin is
effective in reducing the risk of new occurrences.

Weinstock, M.A., Bingham, S.F., Cole, G.W., Eilers, D., Naylor, M.F., Kalivas, J., Taylor,
J.R., Gladstone, H.B., Piacquadio, D.J., and DiGiovanna, J.J. Reliability of Counting
Actinic Keratoses Before and After Brief Consensus Discussion. Arch Dermatol 137:1055-1058,
2001