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

NCT ID: NCT00849992

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-11-30

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.

Conditions

Actinic Cheilitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imiquimod 5%

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

Group Type: OTHER

Imiquimod 5%

Intervention Type: DRUG

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

Photodynamic therapy

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

Group Type: OTHER

Photodynamic therapy

Intervention Type: PROCEDURE

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.

Interventions

Imiquimod 5%

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

Intervention Type: DRUG

Photodynamic therapy

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.

Intervention Type: PROCEDURE

Other Intervention Names

Aldara

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stein H Sundstrøm, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

St. Olavs Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

20115

Identifier Type: -

Identifier Source: org_study_id