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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:
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Imiquimod
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 21, 2006
Last Updated: September 24, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on June 17, 2013