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Clinical Trial
. 2025 Dec;93(6):1489-1498.
doi: 10.1016/j.jaad.2025.08.031. Epub 2025 Aug 20.

Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study

Todd Schlesinger  1 , M Shane Chapman  2 , John H Tu  3 , Joel L Cohen  4 , John Strasswimmer  5 , Nathalie C Zeitouni  6 , Abel Torres  7 , S Sasha Jazayeri  8 , Mitchel P Goldman  9 , Sherrif F Ibrahim  10 , Edward L Lain  11 , Megan P Couvillion  12 , Suzanne Bruce  12 , Vivian T Laquer  13 , C William Hanke  14 , David M Ozog  15 , Jane Schneider  16 , Orit Markowitz  16 , Brian Berman  17 , Mark S Nestor  17 , Michael H Gold  18 , Girish S Munavalli  19 , Douglass W Forsha  20 , Daniel M Siegel  21 , David Mrohs  22 , Beate Schmitz  22 , Ruth Schäning  22 , Nicole Pospiech  23 , Jon Lyons  24 , Montserrat Foguet  23 , Matthias Lübbert  25 , Hermann Lübbert  26 , David M Pariser  27
Affiliations
Free article
Clinical Trial

Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study

Todd Schlesinger et al. J Am Acad Dermatol. 2025 Dec.
Free article

Abstract

Background: Surgical procedures remain the gold standard for treating basal cell carcinoma (BCC), although commonly associated with cosmetic defects. The demand for noninvasive alternatives remains high.

Objective: To determine efficacy and safety of red light photodynamic therapy (PDT) with 10% 5-aminolevulinic acid (ALA) gel vs vehicle for treatment of superficial BCC.

Methods: This randomized, double-blind, vehicle-controlled, pivotal phase III study was conducted at 21 centers in the US. Eligible participants had ≥1 naïve superficial BCC and received 1-2 PDT cycles (2 PDTs each cycle) followed by clinical and histological assessment 12 weeks after start of the last PDT cycle.

Results: Of 187 randomized participants, 145 received PDT with 10% ALA gel and 42 with vehicle. Histological clearance was 75.9% with 10% ALA gel vs 19.0% with vehicle (P < .0001). Clinical clearance was 83.4% with 10% ALA gel vs 21.4% with vehicle (P < .0001). A total of 88.1% of participants treated with 10% ALA gel rated the esthetic outcome as very good or good. No previously unknown adverse events occurred.

Limitations: Few participants with lesions on face/scalp; to date, a 60-month follow-up is still ongoing.

Conclusion: 10% ALA gel showed significantly higher clearance rates than vehicle with unproblematic safety and positive esthetic outcome.

Keywords: 10% ALA gel; BF-200 ALA; PDT; RhodoLED; aminolevulinic acid; basal cell carcinoma; photodynamic therapy; randomized clinical trial; red light.

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Conflict of interest statement

Conflicts of interest Dr Schlesinger is a consultant and investigator for AbbVie, Almirall, Biofrontera Bioscience GmbH, Feldan Therapeutics, Galderma and a consultant for Apogee, Regeneron, SUN Pharma, and Verrica Pharmaceuticals. Dr Chapman is an investigator for Biofrontera Bioscience GmbH. Dr Tu is an investigator for Biofrontera Bioscience GmbH. Dr Cohen has served as a clinical research principal investigator as well as a consultant for Biofrontera Bioscience GmbH. Dr Strasswimmer is an investigator for Biofrontera Bioscience GmbH, and serves as an investigator and also as a consultant for Regeneron Pharmaceuticals, Inc. Sun Pharmaceuticals, Inc, and Phio Pharmaceuticals, Inc. Dr Zeitouni is a consultant and investigator for Biofrontera Bioscience GmbH, an investigator speaker bureau and advisory board member of Regeneron Pharmaceuticals, Inc, an investigator and speaker bureau member of Castle Biosciences, an investigator and advisory board member of Sun Pharmaceuticals, Inc, an investigator for Remplimune and Alpha Tau and a consultant for Dermasensor. Dr Torres is an investigator for Biofrontera Bioscience GmbH. Dr Jazayeri declares speakership for Abbvie and Novartis, received grants for clinical research from Abbvie, Alumis, Amgen, Biofrontera Bioscience GmbH, Ventyx Biosciences, Concert Pharmaceuticals, Dermavant, Mindera Health, Bellus, Pfizer, DermTech, BMS, Anaptys, UCB Biopharma, Kiniksa, Eli Lilly, Bausch Health Americas, Novartis, Athenex, Dermira, Boehringer Ingelheim, Regeneron, Sandoz, Leo Pharmaceutical, Genentech, Janssen, Xenoport. Dr Goldman is an investigator and consultant to Biofrontera, Allergan, Galderma, Lumenis, Solta, SkinMedica and SkinCeuticals. Dr Ibrahim is an investigator for Biofrontera Bioscience GmbH. Dr Lain declares financial relationships with AbbVie, Aclaris Therapeutics, Allergan Inc, Almirall, Arcutis, ASLAN Pharmaceuticals, AstraZeneca, Athenix, Biopelle Inc, BioPharmX, Biorasi LLC, Bristol-Myers Squibb, Bricknell Biotech Inc., Cassiopea S.p.a., Celgene, Cellceutics, ChemoCentryx, Cutanea Life Sciences, Cutera Inc, Dermira, Dermavant Sciences Inc., Dow Pharmaceutical Sciences, Dr Reddy's Laboratory, Eli Lilly, Gage Development Company LLC, Galderma, Hovione, Incyte, Kadmon, La Roche-Posay, LEO Pharma, Medimmune, Menlo Therapeutics, Neothetics, Nielsen Holdings N.V, Novartis, Ortho Dermatologics, Pfizer, Promius Pharma LLC, Sebacia Inc., Sienna Labs Inc., SkinCeuticals LLC, Sol-Gel Technologies, UCB, Valeant Pharmaceuticals, and Verrica Pharmaceuticals. Dr Couvillion is an investigator for AbbVie, Alumis, AnaptysBio, Arcutis Biotherapeutics, Biofrontera Bioscience GmbH, Cara Therapeutics, Castle Biosciences, Concert Pharmaceuticals, Dr Reddy's Laboratories, Eirion Therapeutics, Incyte, Janssen Biotech, Nielsen Bioscience Inc., Ortho Dermatologics, Timber Pharmaceuticals, TrialSpark, Inc., VeraDermics Inc., and Verrica Pharmaceuticals, is an investigator and speaker for Eli Lilly and Pfizer Inc., is a speaker for Revance therapeutics Inc., and consultant for Allergan Aesthetics and Dermavant Sciences Inc. Dr Bruce was an investigator for Biofrontera Bioscience GmbH. Dr Laquer is an investigator for Biofrontera Bioscience GmbH. Dr Hanke is an investigator for AbbVie, Biofrontera Bioscience GmbH, and Castle Biosciences, Inc., and received honoraria as a speaker for Sanofi/Regeneron and Sun Pharmaceutical Industries Ltd. Dr Ozog is an investigator for Biofrontera Bioscience GmbH. Dr Schneider is an investigator for Biofrontera Bioscience GmbH. Dr Markowitz is an investigator for Regeneron, DAMAE Medical, Candela Medical, Galderma, Bristol Myers Squibb, Janssen, Dermtech, Amgen, Eli Lilly, Celldex, Acelyrin, Alumis, Incyte, Pfizer, RAPT, Sanofi, Evommune, Incyte, Inmagene, Argenx, and Celldex. Dr Berman is a consultant and investigator for Sun Pharmaceuticals, Biofrontera, Sensus, Sirnaomics, Aiviva, Minolabs, Mediwound, and consultant/advisor for Thirona, Pfizer, BMS, and Novartis. Dr Nestor is an investigator for Biofrontera Bioscience GmbH and Sun Pharmaceutical Industries LTD and advisory board Sun Pharmaceutical Industries LTD. Dr Gold is an investigator for Biofrontera Bioscience GmbH. Dr Munavalli is an investigator for Biofrontera Bioscience GmbH. Dr Forsha is a speaker for UCB and Pfizer. Dr Siegel declares financial relationships with Avita, Bifrontera AG, Caliber Imaging, and Diagnostics Inc., Cara Therapeutics, DermaSensor Inc., Elsevier Inc., Feldan Therapeutics, Greenway Therapeutix, Lazarus Enterprises Inc., Logical Images, Medforce Technologies Inc., Modernizing Medicine, MycoMedica Life Sciences, Novascan, Omnilux, Or-Genix Therapeutics, Plasmend, Pulse Biosciences, RaMedical, RBC Consultants, Regeneron, Seaspire Skincare, SkinVision, SPC Dermatology, Strata Skin Sciences, Takeda Pharmaceuticals USA Inc., Tetros Group, Verrica Pharmaceuticals Inc. Drs Mrohs, Schmitz, Lübbert, Hermann Lübbert, Foguet, Pospiech, and Author Schäning were or are employees of Biofrontera Bioscience GmbH and may hold stock options. Dr Lyons is an employee of Biofrontera, Inc., and may hold stock options. Dr Pariser is an investigator for Biofrontera, Novartis, and Regeneron and was the chair of a Data Safety Monitoring Board for Bristol-Myers-Squibb.

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