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

Norwegian University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Actinic Cheilitis

Treatments: Drug: Imiquimod 5%; Procedure: Photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00849992

20115

Details and patient eligibility

About

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.

Full description

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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Imiquimod 5%

Other group

Description:

Patients randomized to this arm will receive treatment with imiquimod 5%

Treatment:

Drug: Imiquimod 5%

Photodynamic therapy

Other group

Description:

Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area.

Treatment:

Procedure: Photodynamic therapy