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

Phase 4

Completed

• Conditions: Actinic Cheilitis
• Interventions: Drug: Imiquimod 5%; Procedure: Photodynamic therapy

• Registration Number: NCT00849992
• Lead Sponsor: Norwegian University of Science and Technology

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 analysis), epidemiological data and follow-up data.

Detailed Description

Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.

Study Timeline

• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-24
• Study Start: 2009-03
• Primary Completion: 2013-03
• Study Completion: 2013-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imiquimod 5%	Imiquimod 5%	Patients randomized to this arm will receive treatment with imiquimod 5%
Photodynamic therapy	Photodynamic therapy	Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area.

Primary Outcome Measures

Name	Time	Method
clinical and pathological complete cure rates.	3 and 12 months after therapy

Secondary Outcome Measures

Name	Time	Method
clinical, safety, epidemiological and histopathological data	post-treatment	Through collecting patient data and post-treatment biopsy

Trial Locations

Locations (1)

St. Olavs Hospital; 🇳🇴 Trondheim, Norway