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Phase 3 trial for the treatment of actinic keratoses on the face and scalp with 3 tubes of Ameluz and the RhodoLED XL lamp

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Trial Profile

Phase 3 trial for the treatment of actinic keratoses on the face and scalp with 3 tubes of Ameluz and the RhodoLED XL lamp

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 01 Jan 2026

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At a glance

  • Drugs Aminolevulinic acid (Primary)
  • Indications Actinic keratosis
  • Focus Adverse reactions
  • Sponsors Biofrontera Pharma GmbH

Most Recent Events

  • 18 Dec 2025 According to a Biofrontera media release, company announced the completion of the transfer of FDA approvals for Ameluz and RhodoLED Lamp Series, including Investigational New Drug Application (IND), to Biofrontera, enabling the company to independently manage ongoing and future clinical development and take full responsibility for manufacturing and marketing in the U.S.
  • 09 Dec 2021 New trial record
  • 02 Dec 2021 According to the Biofrontera Inc media release, this trial is expected to initiate in 2022.

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