Red light photodynamic therapy with BF-200 ALA showed superior efficacy in the treatment of actinic keratosis on the extremities, trunk, and neck in a vehicle-controlled phase III study - 17/04/21

Doi : 10.1016/j.jaad.2021.03.031

Martina Ulrich, MD ^a, Uwe Reinhold, MD ^b, Rolf Dominicus, MD ^c, Roland Aschoff, MD ^d, Rolf-Markus Szeimies, MD ^e, Thomas Dirschka, MD ^f,^⁎
^a CMB Collegium Medicum Berlin GmbH, Berlin, Germany
^b MVZ Dermatologisches Zentrum Bonn GmbH, Bonn, Germany
^c PRO DERMA, Hautarztzentrum Dülmen, Dülmen, Germany
^d Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany
^e Department of Dermatology and Allergology, Klinikum Vest GmbH, Recklinghausen, Germany
^f CentroDerm GmbH, Wuppertal, Germany and Faculty of Health, University Witten-Herdecke, Witten, Germany

^∗Correspondence to: Thomas Dirschka, MD, Heinz-Fangman-Straße 57, D-42287 Wuppertal, Germany.Heinz-Fangman-Straße 57WuppertalD-42287Germany

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Abstract

Background

Actinic keratoses (AK) may occur in all sun-exposed skin areas. Those occurring outside the head area are generally more resistant to treatment than those on the face.

Objective

To determine efficacy and safety of BF-200 ALA versus vehicle in the treatment of mild-to-severe AK located on extremities, trunk, and neck with red light photodynamic therapy (PDT).

Methods

This phase III study had an intra-individual design with 50 patients in 6 centers in Germany. Each patient received a maximum of 2 field-directed PDTs. Clinical end points and 1-year follow-up results were recorded.

Results

BF-200 ALA was superior to the vehicle with respect to total lesion clearance rates (86.0% vs 32.9%; P < .0001) and patient complete clearance per patient's side (67.3% vs 12.2%, P < .0001). One-year overall lesion recurrence rate was 14.1% versus 27.4% (BF-200 ALA vs vehicle; P = .0068). Patients were more satisfied by the cosmetic outcome of BF-200 ALA/PDT than the vehicle/PDT. Adverse events were consistent with the known safety profile of BF-200 ALA/PDT.

Limitations

Small number of severe lesions; limited sample size; unbalanced but representative distribution of AK.

Conclusion

BF-200 ALA showed significantly higher AK clearance rates on extremities, trunk, and neck than the vehicle and was well tolerated.

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Key words : 5-ALA, acral, actinic keratosis, AK, Ameluz, BF-200 ALA, BF-RhodoLED, clinical trial, controlled, extremities, neck, PDT, photodynamic therapy, randomized, red light, red narrow spectrum lamp, trunk

Abbreviations used : AE, AK, ALA, BF-200 ALA, IP, PatCR, PDT, SAE, TEAE, TLCR

Plan

Randomization and statistical methods

Standard protocol approvals, registration, and patient consent

Safety and tolerability

Discussion

Data sharing statement

Conflicts of interest

	Funding sources: The trial was supported by Biofrontera Bioscience GmbH.
	IRB approval status: The relevant Institutional Review Board (IRB) approved the Clinical Study Protocol before the screening of patients (Ethikkommission der Universität Witten/Herdecke; Registration number: F-90/2017).
	Reprints not available from the authors.