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

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.

Conditions

• Actinic Keratosis
• Natural Daylight Photodynamic Therapy

Interventions

DRUG

Aminolevulinic Acid

A 0,25mm-thick layer of BF-200 ALA (aminolevulinic acid, Ameluz®) light sensitizer gel is applied on one randomized treatment side of face.

DRUG

Methyl 5-aminolevulinate

A 0,25mm-thick layer of MAL (methyl 5-aminolevulinate, Metvix®) light sensitizer cream is applied on one randomized treatment side of face.

Sponsors & Collaborators

• Päijänne Tavastia Central Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Vaasa Central Hospital, Vaasa, Finland

  collaborator OTHER

• Tampere University

  collaborator OTHER

• STUK - Radiation and Nuclear Safety Authority: Finland

  collaborator UNKNOWN

• Joint Authority for Päijät-Häme Social and Health Care

  lead OTHER

Principal Investigators

• Janne Rasanen, Lic. Med. · Päijänne Tavastia Central Hospital

• Mari Gronroos, D.Med.Sc. · Päijänne Tavastia Central Hospital

• Noora Neittaanmaki-Perttu, D.Med.Sc. · Helsinki University Central Hospital

• Mari Salmivuori, Lic. Med. · Päijänne Tavastia Central Hospital

• Leea Ylitalo, D.Med.Sc. · Tampere University Hospital

• Johanna Hagman, D.Med.Sc. · Vaasa Central Hospital, Vaasa, Finland

• Ida Knutar, Lic. Med. · Vaasa Central Hospital, Vaasa, Finland

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2017-10-31

Completion

2017-10-31

Countries

• Finland

Study Locations