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1h Incubation Photodynamic therapy · 1 trial · 1 indication
Outcome 1 is the relative change in the number of inflammatory lesions at the final visit with respect to baseline as assessed by the investigator.
Treatment success is defined as a minimum improvement of the mIGA score by at least 2 and resulting in an mIGA score of 0 (clear) or 1 (almost clear).
| Arm | Type | Description |
|---|---|---|
| 1h incubation BF-200 ALA | EXPERIMENTAL | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation. |
| 3h incubation BF-200 ALA | EXPERIMENTAL | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid) red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 3h incubation. |
| 1h incubation vehicle | PLACEBO_COMPARATOR | Topical application of vehicle to BF-200 ALA red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation. |
| 3h incubation vehicle | PLACEBO_COMPARATOR | Topical application of vehicle to BF-200 ALA red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 3h incubation. |
| Name | Type | Description |
|---|---|---|
| 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) | COMBINATION_PRODUCT | 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) | COMBINATION_PRODUCT | 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) | COMBINATION_PRODUCT | 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) | COMBINATION_PRODUCT | 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). |
Inclusion Criteria: 1. Willingness and ability of the subject to provide informed consent and to sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures. Minors und...
1h Incubation Photodynamic therapy is being studied for the treatment of moderate to severe acne vulgaris in adults. It combines a photosensitizing agent with light activation to treat inflammatory acne lesions. The approach is being developed by Biofrontera Inc. as a dermatology treatment option for patients with acne.
1h Incubation Photodynamic therapy is being developed by Biofrontera Inc., which trades under the ticker BFRI. The company is evaluating the therapy in dermatology, specifically for moderate to severe acne vulgaris. Biofrontera Inc. is the sponsor of the clinical program for this photodynamic therapy approach.
1h Incubation Photodynamic therapy is in Phase 2 clinical development. The completed Phase 2 trial enrolled 120 participants with moderate to severe acne vulgaris. The therapy is investigational and has not been approved for the treatment of acne vulgaris.
The Phase 2 trial NCT05080764 evaluated 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. The trial was completed, enrolled 120 participants, and was conducted in the United States.
Yes. 1h Incubation Photodynamic therapy is also known as ALA-PDT and Ameluz-PDT. These names refer to the same photodynamic therapy approach that uses a photosensitizing agent activated by light. The therapy is being developed by Biofrontera Inc. for moderate to severe acne vulgaris.
The Phase 2 trial NCT05080764 was a randomized, double-blind, placebo-controlled study of 1h Incubation Photodynamic therapy in moderate to severe acne vulgaris. It enrolled 120 participants aged 16 years and older in the United States. The trial has been completed.