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

February 4, 2022 updated by: MEDA Pharma GmbH & Co. KG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Cedex 3
      • Nice, Cedex 3, France
        • Hopital L'Archet 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
250mg of Imiquimod cream application once daily 3 times per week.
Drug: Aldara (Imiquimod)
250mg of Imiquimod cream for application once daily 3 times per week.
Placebo Comparator: 2
250mg vehicle cream for application once daily 3 times per week.
Other: Vehicle cream
250mg vehicle cream for application once daily 3 times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.
Time Frame: 8 weeks after the end of treatment
8 weeks after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MEDA Pharma GmbH & Co. KG

Investigators

  • Principal Investigator: Jean-Paul Ortonne, Professor, CPCAD, Hopital L'Archet 2

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1517-IMIQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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