Actinic Keratosis
Conditions
Keywords
Aldara, Actinic Keratosis
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 addition a qualitative assessment of each technique will be made for performance and ease of use.
Interventions
DRUGAldara (Imiquimod)
250mg of Imiquimod cream for application once daily 3 times per week.
OTHERVehicle cream
250mg vehicle cream for application once daily 3 times per week.
Sponsors
MEDA Pharma GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts. | 8 weeks after the end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy. | 8 weeks after the end of treatment |
Countries
France
Outcome results
None listed