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

This study has been completed.

Sponsor:

Information provided by:

MEDA Pharma GmbH & Co. KG

ClinicalTrials.gov Identifier:

NCT00294320

First received: February 21, 2006

Last updated: September 24, 2008

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 21, 2006

Last Updated Date

September 24, 2008

Start Date ^ICMJE

February 2006

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00294320 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy. [ Time Frame: 8 weeks after the end of treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Actinic Keratosis

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: 1
250mg of Imiquimod cream application once daily 3 times per week.

Intervention: Drug: Aldara (Imiquimod)
Placebo Comparator: 2
250mg vehicle cream for application once daily 3 times per week.

Intervention: Other: Vehicle cream

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00294320

Other Study ID Numbers ^ICMJE

1517-IMIQ

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr Elena Rizova MD. PhD Medical & Scientific Affairs Europe & MENA, Laboratoires 3M Santé

Study Sponsor ^ICMJE

MEDA Pharma GmbH & Co. KG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean-Paul Ortonne, Professor

CPCAD, Hopital L'Archet 2

Information Provided By

MEDA Pharma GmbH & Co. KG

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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