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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

December 10, 2021

Primary Completion Date

August 22, 2025

Study Completion Date

November 30, 2025

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).

Trial Locations (9)

14623

Skin Search of Rochester, Inc, Rochester

17033

ForCare Clinical Research, Tampa

29407

Clinical Research Center of the Carolinas, Charleston

33445

Dermatology Associates PA of the Palm Beaches, Delray Beach

70809

DelRicht Research, Baton Rouge

78660

Austin Institute for Clinical Research Inc., Pflugerville

78759

DermResearch PA, Austin

92121

Cosmetic Laser Dermatology, San Diego

92708

First OC Dermatology, Fountain Valley

Sponsors
All Listed Sponsors
lead

Biofrontera Bioscience GmbH

INDUSTRY

NCT05080764 - 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 | Biotech Hunter | Biotech Hunter