Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2024 Oct:49:104280.
doi: 10.1016/j.pdpdt.2024.104280. Epub 2024 Jul 11.

Effective treatment of actinic keratosis on the hands with red light photodynamic therapy using BF-200 ALA

Martina Ulrich  1 , Uwe Reinhold  2 , Rolf Dominicus  3 , Roland Aschoff  4 , Rolf-Markus Szeimies  5 , Ruth Schäning  6 , Marie-Theres Zeuner  6 , Nicole Pospiech  7 , Thomas Dirschka  8
Affiliations
Free article
Clinical Trial

Effective treatment of actinic keratosis on the hands with red light photodynamic therapy using BF-200 ALA

Martina Ulrich et al. Photodiagnosis Photodyn Ther. 2024 Oct.
Free article

Abstract

Background: Acral actinic keratosis (AK) lesions are considered difficult to treat, and published data for photodynamic therapy (PDT) on these lesions is limited. Thus, we evaluated sustained efficacy, safety, and satisfaction after PDT for AK on the hands.

Methods: We analysed subgroup data for treatment on the hands from a randomised, double-blind, intra-individual phase III study. All participants previously underwent up to two field-directed red light PDTs with 10 % 5-aminolevulinic acid nanoemulsion gel (BF-200 ALA). Assessments included pain during PDT, clearance and recurrence rates, and satisfaction.

Results: 24 participants treated on the hands were included; 21 participants were analysed. Complete clearance rates with BF-200 ALA were 90.9 % (lesion-based) and 76.2 % (per participant's side), both markedly higher than with vehicle. The lesion recurrence rate with BF-200 ALA was 29.0 %. Adverse events reflected the mode of action. Mean pain intensities were 4.8 ± 3.8 (BF-200 ALA) and 0.8 ± 2.1 (vehicle) on an 11-point numeric rating scale. Most participants (81.0 %) rated their satisfaction with BF-200 ALA as very good or good.

Conclusion: This subgroup analysis indicates that PDT with BF-200 ALA provides a suitable treatment for AK lesions on the hands.

Keywords: Acral; Actinic keratosis; Aminolaevulinic acid; BF-Rhodo LED; Hands; Photodynamic therapy; Red light.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest R.A. received honoraria as scientific advisor, trial investigator and lecturer for AbbVie, Boehringer-Ingelheim, Bristol-Myers Squibb, Incyt, Janssen, Leo, Lilly, Novartis, Sanofi-Aventis, and UCB. R.-M.S. has received grants from Almirall, Biofrontera, Dr. Wolff-Group, Galderma, Leo Pharma, Novartis, and photonamic for clinical studies; has received consulting fees and speakers’ honoraria from Abbvie, Almirall, Eli Lilly, Galderma, Janssen, and Leo Pharma, and is Vice-President of the EURO-PDT Society. T.D. has received funding from Almirall, Biofrontera, Galderma, Meda, Schulze & Böhm GmbH for research support; has received consulting fees from Almirall, Biofrontera, GSK, Dr. Pfleger, Galderma, Janssen-Cilag, Leo, Meda, Neracare, Novartis, Scibase, smartinmedia AG, UCB, Vichy; and has received speakers honoraria from Almirall, Biofrontera, Galderma, GSK, infectopharm, Leo, Meda, Neracare, Novartis, Janssen-Cilag, Riemser. R.S. and M.-T.Z. were employees of Biofrontera Bioscience GmbH at the time the manuscript was written. N.P. is an employee of Biofrontera Bioscience GmbH. U.R. and R.D. have no conflict of interest to declare.

Publication types

LinkOut - more resources