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ACTIVE NOT RECRUITING Phase 3

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

NCT05662202 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • COMBINATION_PRODUCT BF-200 ALA and red light LED lamp
  • COMBINATION_PRODUCT Vehicle and red light LED lamp

Study Locations (14)

Texas

  • DermResearch, P.A. — Austin
  • Austin Institute for Clinical Research — Houston
  • Austin Institute for Clinical Research Inc. — Pflugerville

Arizona

  • Medical Dermatology Specialists — Phoenix
  • Alliance Dermatology & Mohs Center — Phoenix

Indiana

  • Laser and Skin Surgery Center of Indiana — Indianapolis
  • The Indiana Clinical Trials Center, PC — Plainfield

New York

  • Skin Search of Rochester, Inc. — Rochester
  • Rochester Dermatologic Surgery — Victor

Colorado

  • Dermatology Practice — Greenwood Village

Florida

  • Dermatology Associates PA of the Palm Beaches — Delray Beach

Georgia

  • Gwinnett Clinical Research Center, Inc. — Snellville

Louisiana

  • DelRicht Research — Baton Rouge

Trial Details

FieldValue
Enrollment Target 172 participants
Start Date 2022-12-12
Est. Completion 2026-06
Phase Phase 3

Sponsor

Biofrontera

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05662202

The ClinicalTrials.gov registry entry for NCT05662202 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biofrontera, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Actinic Keratoses appearing as the primary indexed condition, and to 2 interventions — of which BF-200 ALA and red light LED lamp is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05662202 reports 14 study locations spanning 9 distinct geographic areas — top geographies include Texas, Arizona, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05662202 about?

NCT05662202 is a clinical study titled "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". 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 ...

What is the current status of trial NCT05662202?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2022-12-12. Estimated completion is 2026-06.

What conditions does trial NCT05662202 study?

This clinical trial studies the following conditions: Actinic Keratoses. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05662202?

The interventions under investigation include: BF-200 ALA and red light LED lamp (COMBINATION_PRODUCT), Vehicle and red light LED lamp (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05662202?

This trial is sponsored by Biofrontera, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05662202 being conducted?

This trial has 14 study locations across Arizona, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial