Overview

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