drugset / Trial / NCT02464709
Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)
Phase 4
Completed
72 enrolled
Joint Authority for Päijät-Häme Social and Health Care
Päijänne Tavastia Central Hospital · collabSTUK - Radiation and Nuclear Safety Authority: Finland · collabTampere University · collabTampere University Hospital · collabVaasa Central Hospital, Vaasa, Finland · collab
NaSingle-groupDouble-blindTreatment
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.
Timeline
- Start
- 2015-06
- Primary completion
- 2017-10
- Completion
- 2017-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 2 g | Topical |
| Subject | methyl aminolevulinate | Small molecule | 2 g | Topical |