Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®) and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL. Result of the treatment is assessed with clinical examination 12 months after treatment. The investigators will also compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Joint Authority for Päijät-Häme Social and Health Care
• Collaborators: Päijänne Tavastia Central Hospital; STUK - Radiation and Nuclear Safety Authority: Finland; Tampere University; Tampere University Hospital; University of Tampere; Vaasa Central Hospital, Vaasa, Finland
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate; Photosensitizing Agents

Criteria

Inclusion Criteria:

• Patients with widespread AK lesions symmetrically on face or scalp (at least 3 actinic keratoses symmetrically on face or scalp)

• AKs of grade I-II

Exclusion Criteria:

• Thick grade III AKs

• Previous treatment for actinic keratosis on the same skin area during preceding 6 months

• Porfyria or solar dermatitis

• Allergy for photosensitizers used in the study

• Pregnant or breastfeeding patients

• Impaired general condition (patient can't manage required 2 hours in sunlight outdoors)