Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp

U Reinhold; W G Philipp-Dormston; T Dirschka; R Ostendorf; R Aschoff; C Berking; A Jäger; B Schmitz; M Foguet; R-M Szeimies

doi:10.1111/jdv.20452

Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp

J Eur Acad Dermatol Venereol. 2024 Dec 12. doi: 10.1111/jdv.20452. Online ahead of print.

Authors

U Reinhold¹, W G Philipp-Dormston^{2

3}, T Dirschka^{3

4}, R Ostendorf⁵, R Aschoff⁶, C Berking⁷, A Jäger⁸, B Schmitz⁸, M Foguet⁸, R-M Szeimies⁹

Affiliations

¹ MVZ Dermatological Center Bonn, Bonn, Germany.
² Hautzentrum Köln, Cologne, Germany.
³ Faculty of Health, University Witten/Herdecke, Witten, Germany.
⁴ Private Practice, Wuppertal-Barmen, Germany.
⁵ Private Practice, Mönchengladbach, Germany.
⁶ Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
⁷ Department of Dermatology, CCC Erlangen-EMN, CCC WERA, Bavarian Center for Cancer Research (BZKF), Uniklinikum Erlangen, Erlangen, Germany.
⁸ Biofrontera Bioscience GmbH, Leverkusen, Germany.
⁹ Department of Dermatology and Allergology, Vest Clinic, Recklinghausen, Germany.

PMID: 39666443
DOI: 10.1111/jdv.20452

Abstract

Background: In actinic keratosis (AK), field cancerization describes areas of skin where multiple visible AK lesions are surrounded by healthy looking skin containing non-visible (subclinical) lesions. As all AK lesions have a risk of progression to cutaneous squamous cell carcinoma, experts advise field-directed treatment. Photodynamic therapy (PDT) is an effective field-directed treatment option for AK; however, long-term efficacy data are still scarce.

Objectives: This publication presents follow-up data of a phase III study evaluating the efficacy and safety of field-directed PDT.

Methods: The study was conducted in seven centres in Germany. For PDT, participants with AKs on the face and scalp (treatment area of 20 cm²) had received up to two field-directed PDTs using BF-200 ALA or placebo, and illumination with narrow-spectrum red light. Only participants or lesions with complete response 12 weeks after the last PDT were assessed for recurrences. The treatment area was evaluated 6 and 12 months after the last PDT for recurrence, cosmetic outcome and new lesions.

Results: Fifty-four participants in the BF-200 ALA and 30 in the placebo group entered the follow-up. The probability of a participant to be initially completely cleared and to remain cleared for 12 months was 57.4% for BF-200 ALA versus 20.0% for placebo. The probability of a lesion to be initially cleared and remain cleared for 12 months was 85.4% for BF-200 ALA versus 31.5% for placebo. 83.3% of participants with cosmetic impairment at baseline rated the cosmetic outcome 12 months after PDT with BF-200 ALA as very good or good. All parameters of skin quality further improved during follow-up.

Conclusions: We showed that effectiveness of field-directed PDT with BF-200 ALA and narrow-spectrum red light was maintained during follow-up. Based on our results, field-directed PDT is a beneficial long-lasting treatment for AK patients.

Clinical trial registration numbers: 2013-002510-12 (EudraCT); NCT01966120 (Clinicaltrials.gov).

Associated data

ClinicalTrials.gov/NCT01966120

Grants and funding

Biofrontera Bioscience GmbH