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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: 12 Oct 2024

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At a glance

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

Most Recent Events

  • 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.
  • 01 Apr 2022 Results assessing systemic absorption from dermal application during PDT, ALA and its key active metabolite protoporphyrin IX (PpIX) were analyzed in 2 trials (NCT04319159 & EudraCT2013-000139-28) published in the Clinical Pharmacology in Drug Development.
  • 13 Oct 2020 Status changed from active, no longer recruiting to completed.

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