Cryosurgery and Cream Combination for Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Carac Cream; Placebo Cetaphil cream
Intervention type(s): Drug; Drug
Intervention description(s): Carac Cream will be used once daily for seven consecutive days; Placebo Cetaphil Cream will be used once daily for seven consecutive days
Other intervention name(s): Cetaphil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Wake Forest; Actinic Keratosis; Cryosurgery; Cream