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

Actinic Cheilitis Clinical Trial

Official title:

Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849992
• Other study ID #: 20115
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2009
• Last updated: May 12, 2017
• Start date: March 2009
• Est. completion date: November 2013

Study information

• Verified date: May 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Cheilitis

Intervention

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

Procedure:
• 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.

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical and pathological complete cure rates.		3 and 12 months after therapy
Secondary	clinical, safety, epidemiological and histopathological data	Through collecting patient data and post-treatment biopsy	post-treatment