Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses

Derm Research @ 888 Inc.60 enrolled

Overview

Study Aims: * To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy. * To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups. Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.

Evaluation of: (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy. Study Aims: * To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups. * To assess and compare the efficacy of the 2 different treatment groups. * To assess and compare the safety of the 2 different treatment groups. Study Design: 6 visits over 62 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Keratosis Actinic Keratosis

Interventions

Imiquimod used as an adjunct to cryotherapyDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of actinic keratosis with 4 or more discreet lesions on the face or balding scalp. Lesions must be within a treatment area not exceeding 50 cm2 (combined total must not exceed 50 cm2) * Women of childbearing potential using appropriate contraceptive methods Exclusion Criteria: * Previous treatments with imiquimod for AK in the prescribed area within the past 5 months or cryosurgery in the same area within the past 4 weeks. * Patients unwilling to stay out of the sun or wear protective clothing or to use sunscreen with a minimum of SPF 15 during the study. * Basal or squamous cell carcinomas in the prescribed treatment area in the past 2 years.

Locations (3)

DermResearch @ 888 Inc

Vancouver, British Columbia, Canada

Windsor Clinical Research

Windsor, Ontario, Canada

Centre de Recherche Dermatologique, CRDQ

Sainte-Foy, Quebec, Canada

Outcomes

Primary Outcomes

Recurrence rate and time to recurrence of lesions

Secondary Outcomes

Time to reach treatment success

Percentage of patients who clear

Patient improvement assessment

Data from ClinicalTrials.gov

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