- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175643
Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses
May 8, 2006 updated by: University of British Columbia
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E8
- Clinical Trials Unit, Skin Care Centre, UBC Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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
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Sustained clearance rate at week 8 post-treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason K Rivers, M.D., Division of Dermatology, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
September 11, 2005
First Submitted That Met QC Criteria
September 11, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
May 9, 2006
Last Update Submitted That Met QC Criteria
May 8, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK-IMIQUIMOD CYCLING
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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