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Outcomes of Field-Directed Photodynamic Therapy Using BF-200 ALA in Patients With Actinic Keratosis
TAKE-HOME MESSAGE
- This study reported follow-up data from a phase III trial assessing the outcomes of field-directed photodynamic therapy with BF-200 ALA and illumination with narrow-spectrum red light in patients with actinic keratosis on the face and scalp. The incubation period was 3 hours and involved a "light-tight occlusive dressing." The 12-month probability of clearance for the participants (57.4% vs 20.0%) and lesions (85.4% vs 31.5%) was significantly higher in the BF-200 ALA group than in the placebo group. Overall, 83.3% of the participants rated their cosmetic outcomes as very good or good, and the skin quality parameters continued to improve over time.
- Field-directed photodynamic therapy is an effective and durable treatment for patients with actinic keratosis.
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
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.
Additional Info
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;[EPub Ahead of Print], U Reinhold, WG Philipp-Dormston, T Dirschka, R Ostendorf, R Aschoff, C Berking, A Jäger, B Schmitz, M Foguet, RM SzeimiesFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.