Clinical trial NCT03037541
Conditions: Actinic Keratosis
Keywords: Wake Forest Actinic Keratosis Cryosurgery Cream
Sponsor: Wake Forest University Health Sciences
Start date: 2011-01-05; Completion date: 2013-10-29
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
This is a randomized (1:1), single-blind, placebo controlled, single center prospective study. Subjects will first undergo cryosurgery of all clinically apparent AK lesions, limited to the face or balding scalp. Three weeks after cryosurgery, subjects will then be randomized (1:1 according to standard randomization tables) and directed to apply either Carac 0.5% cream or placebo cream (Cetaphil Cream) to the face or balding scalp at bedtime for seven consecutive days, washed off each following morning. Each does of study cream will be applied at approximately the same time of day and will remain on the skin for approximately eight hours. Subject evaluation, Investigator Global Assessments, Quality of Life lesion counts and photography shall be performed at Baseline. At Week 3, study drug will be dispensed and the global assessments and assessment of improvement will be performed. A Medication Tolerability Assessment will occur at Week 4 when the study drug will be returned. Investigator Global Assessment, lesion count, Global Assessment of Improvement and Quality of Life will be measured at Week 8 and Week 26 (or end of study). Photography will be done at Week 26 or end of study.

Arms: arm 1: Carac cream (fluorouracil) 0.5% applied daily on the face for one week arm 2: Placebo Cetaphil cream applied daily on the face for one week
Interventions: intervention 1: Carac Cream intervention 2: Placebo Cetaphil cream
Intervention descriptions: intervention 1: Carac Cream will be used once daily for seven consecutive days intervention 2: Placebo Cetaphil Cream will be used once daily for seven consecutive days

Protocol documents: