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

Phase 3

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Aldara (Imiquimod); Other: Vehicle cream

• Registration Number: NCT00294320
• Lead Sponsor: MEDA Pharma GmbH & Co. KG

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-21
• Study First Submitted QC: 2006-02-21
• Study First Posted: 2006-02-22
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2008-09
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aldara (Imiquimod)	250mg of Imiquimod cream application once daily 3 times per week.
2	Vehicle cream	250mg vehicle cream for application once daily 3 times per week.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.	8 weeks after the end of treatment

Trial Locations

Locations (1)

Hopital L'Archet 2; 🇫🇷 Nice, Cedex 3, France