This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of
topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non
melanoma skin cancer/ keratinocytic cancers.
There will be two groups to the study. Individuals, aged 18 years or older, who have
extensive actinic damage, at least 8 AKs and a history of at least one non-melanoma skin
cancer, but are in otherwise general good health, will be given topical diclofenac and
topical DFMO. They will be compared to individuals, aged 18 years or older, who have
extensive actinic damage, but are in otherwise general good health, will be given placebo.
All participants must be at increased risk of non-melanoma skin cancer as evidenced by a
history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses,
and the presence, at baseline, of at least eight actinic keratoses on the face, neck, scalp
and arms. Subjects will be randomized to:
topical diclofenac twice daily and topical DFMO daily
placebo for the topical diclofenac BID and placebo for the topical DFMO daily
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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