Completed
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
Led by University of British Columbia · Updated on 2006-05-09
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
V
Vancouver Coastal Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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).
Trial Site Locations
Total: 1 location
1
Clinical Trials Unit, Skin Care Centre, UBC Dermatology
Vancouver, British Columbia, Canada, V5Z 4E8
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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