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
Overview
- Phase
- Phase 3
- Intervention
- Aldara (Imiquimod)
- Conditions
- Actinic Keratosis
- Sponsor
- MEDA Pharma GmbH & Co. KG
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
1
250mg of Imiquimod cream application once daily 3 times per week.
Intervention: Aldara (Imiquimod)
2
250mg vehicle cream for application once daily 3 times per week.
Intervention: Vehicle cream
Outcomes
Primary Outcomes
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.
Time Frame: 8 weeks after the end of treatment
Secondary Outcomes
- To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.(8 weeks after the end of treatment)