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

Norwegian University of Science and Technology53 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Actinic Cheilitis

Interventions

Imiquimod 5%DRUG

Imiquimod 5% cream used three days a week for 4 weeks

Photodynamic therapyPROCEDURE

Photodynamic therapy involves applying Metvix cream to the affected area followed by illumination. It will be done twice during the study at a 2 week interval.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

St. Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

clinical and pathological complete cure rates.

Time frame: 3 and 12 months after therapy

Secondary Outcomes

clinical, safety, epidemiological and histopathological data

Through collecting patient data and post-treatment biopsy

Time frame: post-treatment

Data from ClinicalTrials.gov

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