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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEDA Pharma GmbH & Co. KG
• Treatments: Imiquimod

Criteria

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