Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults

Summary

The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

COMBINATION_PRODUCT

1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)

The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 1 hour. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps). Other Names: ALA-PDT, Ameluz®-PDT

COMBINATION_PRODUCT

1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)

The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 1h. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).

COMBINATION_PRODUCT

3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)

The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 3 hours. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps). Other Names: ALA-PDT, Ameluz®-PDT

COMBINATION_PRODUCT

3h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)

The treatment field (whole face excluding the periocular area) will be cleansed with gauze soaked with ethanol or isopropanol. Afterwards, approximately 1 tube of study medication will be applied as a thin layer. After drug application, subjects should stay inside for 3h. Post incubation, red light illumination with BF-RhodoLED® will be performed according to the lamps user manual until a total light energy of 37 J/cm2 was applied. To cover the whole face 2 illuminations will be required which can either be performed subsequentially or in parallel (with 2 lamps).

Sponsors & Collaborators

• Biofrontera Inc.

  lead INDUSTRY

Principal Investigators

• Mitchel P Goldman, MD · Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-10

Primary Completion

2025-08-22

Completion

2026-01-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations