Cryosurgery and Cream Combination for Actinic Keratosis
Status:
Completed
Trial end date:
2013-10-29
Target enrollment:
Participant gender:
Summary
Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as
tolerated, though local irritation often occurs within the first week of treatment and
increases in a dose-dependent manner. In this study, the investigators will examine the
combination of standard cryosurgery treatment followed by a shortened course of topical
fluorouracil cram. The investigators anticipate that a one week treatment course will
maintain overall effectiveness when combined with previous cryosurgery, but will reduce the
overall adverse effects of topical therapy due to the reduced treatment time and the presence
of fewer baseline lesions to treat. This treatment approach may provide a more acceptable
risk/benefit ratio option for patients with more extensive disease and simplify standard
combination treatment options. The primary objective is to evaluate the efficacy of
combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and
placebo in the treatment of actinic keratosis lesions. The efficacy of this combination
therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter
will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.