Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses

Actinic Keratoses Clinical Trial

Official title:

Open-Label Study to Assess Safety and Efficacy of Imiquimod 5% Cream Applied 3 Days Per Week in 1 or 2 Cycles for Treatment of Actinic Keratoses on the Head

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175643
• Other study ID #: AK-IMIQUIMOD CYCLING
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2005
• Last updated: May 8, 2006
• Start date: February 2005
• Est. completion date: November 2005

Study information

• Verified date: May 2006
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

It is believed that imiquimod 5% cream has the potential to be an effective treatment for actinic keratoses. The purpose of this study is to evaluate the duration of the effect of topical imiquimod 5% topical cream for the treatment of actinic keratoses.

Description:

This study will assess the safety and efficacy of imiquimod 5% cream applied to actinic keratoses on the head to reduce the size of lesions. The objective is to analyze the effect of dose cycling with respect to the complete clearance rate when imiquimod 5% cream is applied 3 times per week for 4 weeks in 1 or 2 cycles. The complete clearance rate is defined as the proportion of subjects with no clinically visible AK lesions in the treatment area at the end of cycle 1 or the end of cycle 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• At least 18 years of age.

• Have a total of 4 to 8 clinically typical, discrete, non-hyperkeratotic, non-hypertrophic AK lesions located within a contiguous 25 cm2 treatment area (balding scalp or face, but not both).

• Free of any significant findings (e.g. tattoos) in the potential application site area that may impair examination of treatment or surrounding area.

• Willing to eliminate tanning bed/sun parlor use for duration of study.

Exclusion Criteria:

• Evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease.

• Any dermatological disease and or condition in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination (e.g. rosacea, psoriasis, atopic dermatitis, eczema).

• Confirmed SCC, BCC anywhere on the head.

• Share a household where there is a person participating in a concurrent clinical study of imiquimod or being treated with imiquimod 5% topical cream.

• Active chemical dependency or alcoholism, as assessed by investigator.

• Females who are pregnant, breast-feeding or considering becoming pregnant while on the study.

• Females with childbearing unwilling to practice an effective method of contraception, as defined by the investigator for the duration of the study as well as one month after completion.

• Received any treatment, products or procedures within the designated time period prior to the prestudy visit as listed on page 4 of the protocol (Version 03 dd March 2003).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• imiquimod

Locations

Country	Name	City	State
Canada	Clinical Trials Unit, Skin Care Centre, UBC Dermatology	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	3M, Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

(1.) Somani N, Rivers JK. Imiquimod 5% cream for the treatment of actinic keratoses. Skin Therapy Lett 2005;10(2):1-6. (2.) Rivers JK. Topical 3% diclofenac in 2.5% hyaluronan gel for the treatment of actinic keratoses. Skin Therapy Lett 2004;9(1):1-3. (3.) Rivers JK, Arlette J, Shear N, Guenther L, Carey W, Poulin Y. Topical treatment of actinic keratoses with 3.0% diclofenac in 2.5% hyaluronan gel. Br J Dermatol 2002;146 (4.) Rivers JK, McLean DI. An open study to assess the efficacy and safety of topical 3% diclofenac in a 2.5% hyaluronic acid gel for the treatment of actinic keratoses. Arch Dermatol 1997;133(10):1239-42.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clearance rate - defined as the proportion of subjects at the end of cycle 1 or cycle 2 with no (zero) clinically visible AK lesions in the treatment area.
Secondary	Partial clearance rate - defined as the proportion of subjects at the end of cycle 2 with at least 75% reduction from the number of AK lesions counted at baseline in the treatment area
Secondary	Sustained clearance rate at week 8 post-treatment.