126
Participants
Start Date
December 10, 2021
Primary Completion Date
August 22, 2025
Study Completion Date
November 30, 2025
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"
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).
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"
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).
Skin Search of Rochester, Inc, Rochester
ForCare Clinical Research, Tampa
Clinical Research Center of the Carolinas, Charleston
Dermatology Associates PA of the Palm Beaches, Delray Beach
DelRicht Research, Baton Rouge
Austin Institute for Clinical Research Inc., Pflugerville
DermResearch PA, Austin
Cosmetic Laser Dermatology, San Diego
First OC Dermatology, Fountain Valley
Lead Sponsor
Biofrontera Bioscience GmbH
INDUSTRY