Status:
COMPLETED
Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.
Detailed Description
Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In additio...
Eligibility Criteria
Inclusion
- At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions
- Free of any significant findings (e.g tattoos) in the potential application site area.
- Willing to discontinue sun-tanning and use of sunbed/sun parlour use
- Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area.
- Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment
Exclusion
- Evidence of unstable or uncontrolled clinically significant medical condition.
- Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod.
- Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days.
- Have active chemical dependency or alcoholism
- Have know allergies to any excipient or study cream
- Have received previous treatment with imiquimod for any indication within the treatment area.
- Known to be affected by porphyria
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00294320
Start Date
February 1 2006
End Date
January 1 2007
Last Update
February 7 2022
Active Locations (1)
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1
Hopital L'Archet 2
Nice, Cedex 3, France