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Photosensitizer

Photodynamic Therapy for Acne

Phase 2

Recruiting

Led By Mitchel P Goldman, MD

Research Sponsored by Biofrontera Bioscience GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of ≥20 inflammatory and ≥20 non-inflammatory Acne vulgaris lesions on the face

Females of reproductive potential must have a negative serum pregnancy test and must use adequate and highly effective or two effective methods of contraception throughout the study

Must not have

Subjects with sunburn or other possible confounding skin conditions within or in close proximity to treatment field

Beard or other facial hair that might interfere with the study assessments unless subject agrees to be clean-shaven throughout the entire study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 or 8 weeks after the 3rd pdt

Summary

This trial tests whether a light-based therapy is effective and safe for treating moderate to severe acne.

Who is the study for?

Adults with moderate to severe facial acne (IGA ≥3), willing to stop other topical treatments and able to undergo up to 3 photodynamic therapies in 8-10 weeks. Participants must be generally healthy, females using contraception, and over 16 years old. Excluded are those allergic to ALA or ingredients in BF-200 ALA, have certain skin conditions or facial hair that affects study assessments unless they shave.

What is being tested?

The trial is testing the effectiveness of Ameluz® with BF-RhodoLED® lamp for treating acne through photodynamic therapy (PDT). It compares a one-hour and three-hour PDT session using Ameluz® against a placebo treatment without active ingredients.

What are the potential side effects?

Potential side effects may include skin reactions at the site of application such as redness, swelling, burning sensation; sensitivity to light; temporary changes in skin color; itching; scaling; dryness; stinging sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have more than 20 red and 20 non-red acne spots on my face.

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I am not pregnant and will use effective birth control during the study.

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I have moderate to severe facial acne.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have sunburn or skin issues near the treatment area.

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I agree to shave my beard or facial hair for the study.

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I have a skin condition like eczema, psoriasis, or a type of skin cancer.

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I have four or more bumps from acne on my face.

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I have used skin medication before screening.

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I have not used certain medications recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 or 8 weeks after the 2nd pdt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 or 8 weeks after the 2nd pdt

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 or 8 weeks after the 2nd pdt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Photochemotherapy

Secondary study objectives

Change in the number of inflammatory and/or non-inflammatory lesions (absolute change and/or percentage change from baseline) as assessed by investigator.

Change in the number of inflammatory and/or non-inflammatory lesions (absolute change and/or percentage change from baseline) as assessed by the Canfield algorithm

Inflammation

+8 more

Other study objectives

Application site discomfort reported by the subjects.

Application site skin reactions assessed by the investigator.

Changes in blood pressure

+7 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 3h incubation BF-200 ALAExperimental Treatment1 Intervention

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.

Group II: 1h incubation BF-200 ALAExperimental Treatment1 Intervention

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.

Group III: 3h incubation vehiclePlacebo Group1 Intervention

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

Group IV: 1h incubation vehiclePlacebo Group1 Intervention

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

0 / 9Eligibility criteria met