Trial | NCT00294320  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    imiquimod ...

  • Study Participants

    12
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.
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.
Study Started
Feb 28
2006
Primary Completion
Jan 31
2007
Study Completion
Jan 31
2007
Last Update
Feb 07
2022

Drug Aldara (Imiquimod)

250mg of Imiquimod cream for application once daily 3 times per week.

Other Vehicle cream

250mg vehicle cream for application once daily 3 times per week.

1 Experimental

250mg of Imiquimod cream application once daily 3 times per week.

2 Placebo Comparator

250mg vehicle cream for application once daily 3 times per week.

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
No Results Posted