FindMyKOL
Clinical trialNCT05662202CompletedPhase 3Interventional

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

SponsorBiofrontera Inc.Enrollment172Actinic Keratoses
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The aim of this study is to test the safety, tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Nathalie Zeitouni, MD

    Medical Dermatology Specialists; Phoenix, Arizona, United States

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Alliance Dermatology & Mohs Center

    Phoenix, Arizona, United States

  • Medical Dermatology Specialists

    Phoenix, Arizona, United States

  • Dermatology Practice

    Greenwood Village, Colorado, United States

  • Dermatology Associates Pa of the Palm Beaches

    Delray Beach, Florida, United States

  • Gwinnett Clinical Research Center, Inc.

    Snellville, Georgia, United States

  • Laser and Skin Surgery Center of Indiana

    Indianapolis, Indiana, United States

  • the Indiana Clinical Trials Center, Pc

    Plainfield, Indiana, United States

  • Delricht Research

    Baton Rouge, Louisiana, United States

  • Skin Search of Rochester, Inc.

    Rochester, New York, United States

  • Rochester Dermatologic Surgery

    Victor, New York, United States

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, United States

  • Dermresearch, P.A.

    Austin, Texas, United States

  • Austin Institute for Clinical Research

    Houston, Texas, United States

  • Austin Institute for Clinical Research Inc.

    Pflugerville, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
12 Dec 2022
Primary completion
3 Sept 2025
Completion
1 Jul 2026
Last update posted
21 Aug 2026
Registered enrollment
172
Registry id
NCT05662202

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.