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

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294320
• Other study ID #: 1517-IMIQ
• Status: Completed
• Phase: Phase 3
• Start date: February 2006
• Est. completion date: January 2007

Study information

• Verified date: September 2008
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

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.

Locations

Country	Name	City	State
France	Hopital L'Archet 2	Nice	Cedex 3

Sponsors (1)

Lead Sponsor	Collaborator
MEDA Pharma GmbH & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.		8 weeks after the end of treatment