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

NCT05080764 | Active Not Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: ALA-ACV-CT014
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

ALA-PDT

Outcome Measures

Primary Outcomes (2)

• Relative change in the number of inflammatory lesions (relative change from baseline) 8 weeks after the last PDT as assessed by investigator.

  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.

  8 weeks after the last PDT

• Treatment success defined by a minimum improvement of the modified investigator global assessment (mIGA) score by at least 2 assessed 8 weeks after the last PDT and resulting in an mIGA score of 0 (clear) or 1 (almost clear).

  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).

  8 weeks after the last PDT

Secondary Outcomes (11)

• Absolute and/or percentage change from baseline in the number of lesions as assessed by investigator.

  4 or 8 weeks after the last PDT

• Absolute and percentage change from baseline in the number of lesions as assessed by investigator.

  4 or 8 weeks after the last PDT

• Absolute and percentage change from baseline in the number of lesions as assessed by investigator, only for responders at Visit 3 / 4 weeks after PDT-1.

  4 or 8 weeks after PDT-1

• Absolute and percentage change from baseline in the number of lesions as assessed by investigator, only for responders at Visit 4b / 4 weeks after PDT-2.

  4 or 8 weeks after PDT-2

• Absolute and percentage change in the number of lesions as assessed by investigator, only for responders at Visit 5b / 4 weeks after PDT-3.

  4 or 8 weeks after PDT-3

Other Outcomes (10)

• Frequency and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESI) and treatment-emerged adverse events (TEAEs).

  from screening to study completion, over a duration of up to approximately 25 weeks

• Application site skin reactions assessed by the investigator.

  from screening to study completion, over a duration of up to approximately 25 weeks

• Application site discomfort reported by the subjects.

  from screening to study completion, over a duration of up to approximately 25 weeks

Study Arms (4)

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.

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

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.

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

1h incubation vehicle

PLACEBO COMPARATOR

Topical application of vehicle to BF-200 ALA red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 1h incubation.

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

3h incubation vehicle

PLACEBO COMPARATOR

Topical application of vehicle to BF-200 ALA red light photodynamic therapy (PDT) utilizing BF-RhodoLED® after 3h incubation.

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

Interventions

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 BF-200 ALA

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).

1h incubation vehicle

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 BF-200 ALA

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).

3h incubation vehicle

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 under 18 years of age must be accompanied by the parent(s) or legal guardian(s) at the time of consent signing. The parent(s) or legal guardian(s) must also provide informed consent/HIPAA for the subject.
• Subjects with moderate to severe acne on the face (IGA ≥3).
• Presence of ≥20 inflammatory and ≥20 non-inflammatory (open and closed comedones) Acne vulgaris lesions on the face (should be located within not more than 2 illumination areas) as assessed by investigator.
• All sexes, ≥16 years of age.
• Willingness and ability to comply with study procedures, particularly willingness to receive up to 3 PDTs within 8 to 10 weeks.
• Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study.
• Willingness to stop topical facial treatments other than medical cleansers (i.e. face washes etc.) at least 14 days prior to randomization visit (Visit 2, baseline) and discontinue medical cleansers in the face at least 1 week prior to randomization visit (Visit 2, baseline) and thereafter until the end of study (use of soap is allowed but the product used should not be changed during the study).
• Females of reproductive potential must have a negative serum pregnancy test and must use an adequate and highly effective or two effective methods of contraception throughout the study. (If hormonal contraception is used, the same product and dose should be taken for at least 6 months before the first treatment and throughout the entire study.)

You may not qualify if:

• Any known history of hypersensitivity to ALA, porphyrins or excipients of BF-200 ALA.
• History of soy or peanut allergy.
• Subjects with sunburn or other possible confounding skin conditions (e.g. wounds, irritations, bleeding or skin infections) within or in close proximity (\< 5 cm distance) to treatment field. (Reassessment of subjects is allowed once if the sunburn or other confounding skin conditions is/are expected to resolve within the screening period.
• Reassessment can be done on the day of the actual treatment.)
• Clinical diagnosis of atopic dermatitis and other cutaneous conditions (e.g. lupus erythematosus), Bowen's disease, BCC, eczema, psoriasis, acne conglobate, acne fulminans, or secondary acne (steroid-induced acne, perioral dermatitis, acne rosacea), squamous cell carcinoma, other malignant or benign tumors in the treatment field.
• Clinically significant (CS) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
• Presence of photodermatoses or porphyria
• Metastatic tumor or tumor with high probability of metastasis
• Infiltrating skin neoplasia (suspected or known)
• Unstable cardiovascular disease (New York Heart Association class III, IV)
• Unstable hematologic (including Myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition
• Unstable collagen-vascular condition
• Unstable gastrointestinal condition
• Immunosuppressive condition
• Presence of clinically significant inherited or acquired coagulation defect

Sponsors & Collaborators

• Biofrontera Inc.: lead

Study Sites (9)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Dermatology Associates PA of the Palm Beaches

Delray Beach, Florida, 33445, United States

Location

ForCare Clinical Research

Tampa, Florida, 17033, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

Skin Search of Rochester, Inc

Rochester, New York, 14623, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

DermResearch PA

Austin, Texas, 78759, United States

Location

Austin Institute for Clinical Research Inc.

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Mitchel P Goldman, MD

  Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 18, 2021
• Study Start: December 10, 2021
• Primary Completion: August 22, 2025
• Study Completion: January 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (9)