Cryosurgery and Cream Combination for Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Carac Cream; Placebo Cetaphil cream
Intervention description: Carac Cream will be used once daily for seven consecutive days; Placebo Cetaphil Cream will be used once daily for seven consecutive days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Wake Forest; Actinic Keratosis; Cryosurgery; Cream

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be male or female and at least 18 years of age. Each subject must demonstrate
             good health as determined by a baseline medical history.

          -  Female subjects myst be of either non-childbearing potential, or childbearing
             potential provided: negative urine pregnancy test and using two acceptable methods of
             effective contraception (abstinence, birth control pills.patch, DepoProvera, tubal
             ligation, vasectomy of the partner in a monogamous relationship, condoms and
             spermicidal form or gel and/or cervical cap or sponge), as determined by the
             investigator

          -  At least eight clinically typical, visible and discrete AK lesions within the
             treatment area on the face or balding scalp

          -  Subjects must be able and willing to comply with study procedures and have provided
             written informed consent.

        Exclusion Criteria:

          -  Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision,
             curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing)
             within the selected treatment area in the previous four weeks.

          -  Treatment with systemic medications that suppress the immune system within the
             previous four weeks.

          -  Field treatments with topical 5-FU, imiquimod, diclofenac, or photodynamic therapy, or
             more widespread field treatment with dermabrasion, medium or greater depth chemical
             peel, or laser resurfacing within the previous six months.

          -  Any known dihydropyrimidine dehydrogenase enzyme deficiency.

          -  In addition, subjects who have any skin condition or disease that may require
             concurrent therapy or may confound the evaluation as determined by the investigator,
             or a history of hypersensitivity to any of the formulation components will be excluded
             from study.

          -  Subjects may not use other topical agents such as glycolic acid products,
             alpha-hydroxy acid products, retinoids and chemical peel agents on teh treatment area
             while on study. The use of these products are not allowed four weeks prior to study
             enrollment. Introduction of any other prescription medication, topical or systemic for
             actinic keratosis while participating in the study is not permitted.

          -  Pregnant women, women who are breast feeding, or women of childbearing potential who
             are not practicing two acceptable methods of effective contraception.