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
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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.
Le texte complet de cet article est disponible en PDF.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
Funding sources: The trial was supported by Biofrontera Bioscience GmbH. |
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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). |
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Reprints not available from the authors. |
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