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

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Aldara (Imiquimod)
Vehicle cream
Sponsored by
MEDA Pharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Actinic Keratosis focused on measuring Aldara, Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital L'Archet 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

250mg vehicle cream for application once daily 3 times per week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2006
Last Updated
February 4, 2022
Sponsor
MEDA Pharma GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT00294320
Brief Title
Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MEDA Pharma GmbH & Co. KG

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Aldara, Actinic Keratosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
250mg of Imiquimod cream application once daily 3 times per week.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
250mg vehicle cream for application once daily 3 times per week.
Intervention Type
Drug
Intervention Name(s)
Aldara (Imiquimod)
Intervention Description
250mg of Imiquimod cream for application once daily 3 times per week.
Intervention Type
Other
Intervention Name(s)
Vehicle cream
Intervention Description
250mg vehicle cream for application once daily 3 times per week.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.
Time Frame
8 weeks after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Ortonne, Professor
Organizational Affiliation
CPCAD, Hopital L'Archet 2
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital L'Archet 2
City
Nice
State/Province
Cedex 3
Country
France

12. IPD Sharing Statement

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

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