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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00294320
First Posted: February 22, 2006
Last Update Posted: September 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MEDA Pharma GmbH & Co. KG
  Purpose
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.

Condition Intervention Phase
Actinic Keratosis Drug: Aldara (Imiquimod) Other: Vehicle cream Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by MEDA Pharma GmbH & Co. KG:

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. [ Time Frame: 8 weeks after the end of treatment ]

Secondary Outcome Measures:
  • To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy. [ Time Frame: 8 weeks after the end of treatment ]

Enrollment: 12
Study Start Date: February 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294320


Locations
France
Hopital L'Archet 2
Nice, Cedex 3, France
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Investigators
Principal Investigator: Jean-Paul Ortonne, Professor CPCAD, Hopital L'Archet 2
  More Information

Responsible Party: Dr Elena Rizova MD. PhD Medical & Scientific Affairs Europe & MENA, Laboratoires 3M Santé
ClinicalTrials.gov Identifier: NCT00294320     History of Changes
Other Study ID Numbers: 1517-IMIQ
First Submitted: February 21, 2006
First Posted: February 22, 2006
Last Update Posted: September 26, 2008
Last Verified: September 2008

Keywords provided by MEDA Pharma GmbH & Co. KG:
Aldara
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers