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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Actinic Keratoses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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imiquimod

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Jason K Rivers, M.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Dermatology, University of British Columbia

Locations

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Clinical Trials Unit, Skin Care Centre, UBC Dermatology

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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(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.

Reference Type BACKGROUND

Other Identifiers

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AK-IMIQUIMOD CYCLING

Identifier Type: -

Identifier Source: org_study_id