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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
A Randomized, Parallel-Group, Vehicle-Controlled, Double-Blind Study of Topical Imiquimod 5% Cream Used as an Adjunct to Cryotherapy in the Management of Actinic Keratoses, With a Long-Term (1 Year) Follow-Up

Conditions
-----------------
Keratosis, Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Imiquimod used as an adjunct to cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Imiquimod used as an adjunct to cryotherapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate and time to recurrence of lesions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach treatment success |  |  | 
| Percentage of patients who clear |  |  | 
| Patient improvement assessment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryotherapy, Actinic Keratosis, Imiquimod