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

This study has been completed.

Sponsored by: MEDA Pharma GmbH & Co. KG
Information provided by: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00294320
  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 III

Drug Information available for:   S 26308   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental
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.
2: Placebo Comparator
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, Cedex 3
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:   Laboratoires 3M Santé ( Dr Elena Rizova MD. PhD Medical & Scientific Affairs Europe & MENA )
Study ID Numbers:   1517-IMIQ
First Received:   February 21, 2006
Last Updated:   September 24, 2008
ClinicalTrials.gov Identifier:   NCT00294320
Health Authority:   France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Keratosis
Skin Diseases
Interferons
Imiquimod
Interferon Alfa-2b
Tylosis

Additional relevant MeSH terms:
Interferon Inducers
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008




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