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Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp

Study on safety and results of Ameluz® for skin treatment with light therapy.

Recruiting
18 years and older
All
Phase 3

This study looks at a treatment for actinic keratosis (AK), which are rough, scaly patches on the skin caused by too much sun. The treatment uses a special gel called Ameluz® and a red light lamp called RhodoLED. This is called photodynamic therapy (PDT). The goal is to see if this treatment is safe and works well. Participants will have between 4 to 15 small AK spots, and they will receive up to 2 PDT treatments over about 12 weeks. They must be willing to stop using certain skin products, avoid too much sun, and be healthy enough to participate.

Key Points:
  • Participants will attend multiple visits over approximately 12 weeks.
  • Participants should not have any allergies to ALA (a substance in the gel) or other skin conditions.
  • Women who can have children need a negative pregnancy test and must use effective birth control.
Study details
    Actinic Keratoses

NCT05662202

Biofrontera Bioscience GmbH

25 January 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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