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

This study has been completed.
Vancouver Coastal Health Research Institute
Information provided by:
University of British Columbia Identifier:
First received: September 11, 2005
Last updated: May 8, 2006
Last verified: May 2006
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.

Condition Intervention Phase
Actinic Keratoses
Drug: imiquimod
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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
  • Sustained clearance rate at week 8 post-treatment.

Estimated Enrollment: 20
Study Start Date: February 2005
Estimated Study Completion Date: November 2005
Detailed 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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).
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Please refer to this study by its identifier: NCT00175643

Canada, British Columbia
Clinical Trials Unit, Skin Care Centre, UBC Dermatology
Vancouver, British Columbia, Canada, V5Z 4E8
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Principal Investigator: Jason K Rivers, M.D. Division of Dermatology, University of British Columbia
  More Information

(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. Identifier: NCT00175643     History of Changes
Study First Received: September 11, 2005
Last Updated: May 8, 2006

Keywords provided by University of British Columbia:
actinic keratoses
squamous cell carcinoma

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers processed this record on May 25, 2017