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An Open-label Phase I Study to Evaluate the Pharmacokinetics of 5-aminolevulinic Acid and Protoporphyrin IX in Human Plasma Under Maximal Use Conditions After Topical Application of 3 Tubes of BF-200 ALA 10% Gel for Photodynamic Therapy (PDT) in Subjects Suffering From Actinic Keratosis

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Trial Profile

An Open-label Phase I Study to Evaluate the Pharmacokinetics of 5-aminolevulinic Acid and Protoporphyrin IX in Human Plasma Under Maximal Use Conditions After Topical Application of 3 Tubes of BF-200 ALA 10% Gel for Photodynamic Therapy (PDT) in Subjects Suffering From Actinic Keratosis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Dec 2025

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At a glance

  • Drugs Aminolevulinic acid (Primary)
  • Indications Actinic keratosis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Biofrontera Bioscience GmbH

Most Recent Events

  • 04 Dec 2025 According to a Biofrontera media release, pending positive outcomes of this trial and the corresponding Phase III study, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the Summer of 2026.
  • 04 Dec 2025 According to a Biofrontera media release, Dr. Ted Lain is a key contributor to the Phase 1 study.
  • 07 Oct 2024 According to a Biofrontera media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the Companys sNDA to increase the maximally approved dosage from one to three tubes of Ameluz per treatment. The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz were applied to 116 patients.

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