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Completed

NCT Number: NCT00294320

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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital L'Archet 2

Nice, Cedex 3, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aldara (Imiquimod)

Drug

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

Vehicle cream

Other

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

Primary outcomes

  1. 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 outcomes

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

    Time frame: 8 weeks after the end of treatment

Sponsors and collaborators

Lead sponsor

MEDA Pharma GmbH & Co. KG

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 22, 2006
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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