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Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp

NCT05060237 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-10-17

Study results available
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Summary

The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.

Conditions

  • Actinic Keratosis
  • Keratosis, Actinic
  • Keratosis

Interventions

COMBINATION_PRODUCT

BF-200 ALA and red light LED lamp

Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²), followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing.

Sponsors & Collaborators

  • Biofrontera Bioscience GmbH

    lead INDUSTRY

Principal Investigators

  • Todd Schlesinger, MD · Clinical Research Center of the Carolinas, 1364 Ashley River Road, Charleston, SC 29407, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-04-20
Completion
2023-04-20
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05060237 on ClinicalTrials.gov