Two chemoprevention randomized clinical trials were begun in 1984 to e
valuate retinoids in the prevention of skin cancers. Moderate risk sub
jects with a history of at least 10 actinic keratoses and at most two
prior skin cancers were enrolled in the SKICAP-AK trial and randomized
to 25 000 IU retinol or placebo daily for 5 years. High risk subjects
with a history of at least four prior skin cancers were enrolled in t
he SKICAP-S/B trial and randomized to receive 25 000 IU retinol, 5-10
mg isotretinoin or placebo daily for 3 years. Data from the SKICAP-AK
trial indicate that retinol reduces incidence of first new squamous ce
ll skin cancers but had no effect on the incidence of first new basal
cell skin cancer. The effect of retinoids had no significant benefit o
n squamous or basal cell skin cancers in the high risk subjects on the
SKICAP-S/B trial, although intervention duration was less than planne
d. Daily retinol was effective in preventing squamous cell cancers in
moderate risk subjects. (C) 1997 Elsevier Science Ireland Ltd.