CompletedPhase 4

Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy

Norway53 participantsStarted 2009-03

Plain-language 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 analysis), epidemiological data and follow-up data.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

clinical and pathological complete cure rates.

Timeframe: 3 and 12 months after therapy

Trial details

NCT IDNCT00849992

SponsorNorwegian University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

View on ClinicalTrials.gov More Actinic Cheilitis trials