Status:
COMPLETED
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Conditions:
Actinic Cheilitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin ...
Detailed Description
Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.
Eligibility Criteria
Inclusion
- Clinical findings of actinic cheilitis.
- Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).
- Age above 18.
- Willingness to take post-treatment biopsy.
Exclusion
- Disorders predisposing to photosensitivity (porphyria, SLE).
- Pregnancy or nursing.
- Known allergy to any excipients in the study creams.
- prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00849992
Start Date
March 1 2009
End Date
November 1 2013
Last Update
May 15 2017
Active Locations (1)
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1
St. Olavs Hospital
Trondheim, Norway, 7006