Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study to Evaluate Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-clinical), When Treated With Aldara 5% (Imiquimod) Cream

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Aldara (Imiquimod)
* Other: Vehicle cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>250mg of Imiquimod cream application once daily 3 times per week. | Drug: Aldara (Imiquimod)<br>* 250mg of Imiquimod cream for application once daily 3 times per week.<br>|
| Placebo Comparator: 2<br>250mg vehicle cream for application once daily 3 times per week. | Other: Vehicle cream<br>* 250mg vehicle cream for application once daily 3 times per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy. |  | 8 weeks after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aldara, Actinic Keratosis