Photodynamic Therapy for Acne

Not currently recruiting at 8 trial locations

Overseen By Seth Forman, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Biofrontera Inc.

Must not be taking: Antibiotics, Isotretinoin, Immunosuppressants, others

Disqualifiers: Hypersensitivity, Soy allergy, Atopic dermatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores photodynamic therapy (PDT) to determine its safety and effectiveness for treating moderate to severe acne. Participants will receive either Ameluz® (also known as BF-200 ALA) combined with a special red light or a placebo treatment. The trial seeks individuals with significant facial acne, including at least 20 red, inflamed spots and 20 non-inflamed spots like blackheads or whiteheads. The goal is to assess whether this treatment can reduce acne symptoms and improve skin condition. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain topical and systemic medications before joining. For example, you must stop topical facial treatments at least 14 days before starting and avoid certain systemic acne therapies for up to 6 months prior. If you're on medications with phototoxic or photoallergic potential, you may need a washout period (time without taking the medication) before treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatment with BF-200 ALA (Ameluz®) and red light therapy is generally easy for patients to handle. In previous studies, most participants managed the treatment without major issues. However, some experienced moderate-to-severe pain during therapy. Reports also noted acne-like spots appearing about two days after treatment, but these typically resolved quickly.

The treatment has demonstrated good results, with many acne spots clearing up. While some discomfort might occur, the therapy effectively reduces acne symptoms. Prospective trial participants should consider these possible side effects alongside the potential benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acne?

Unlike standard acne treatments like topical antibiotics or retinoids, BF-200 ALA uses a unique approach called photodynamic therapy (PDT). This involves applying a cream with 7.8% 5-aminolevulinic acid (5-ALA), then activating it with red light using BF-RhodoLED®. What makes this treatment especially exciting is its potential to target acne at a deeper level by destroying acne-causing bacteria and reducing oil production, all without the typical side effects of traditional medications. Researchers are particularly interested in how this method can offer quicker results with less irritation.

What evidence suggests that photodynamic therapy might be an effective treatment for acne?

Research has shown that photodynamic therapy (PDT) with BF-200 ALA effectively treats moderate to severe acne. In this trial, participants will receive either a 1-hour or 3-hour incubation of BF-200 ALA, or a placebo comparator. Studies have found that this treatment, when combined with red light, clears about 86% of acne spots. The therapy involves applying a gel that increases the skin's sensitivity to light, which helps kill acne-causing bacteria when exposed to a special red light. Additionally, PDT with BF-200 ALA has provided long-lasting results for various types of acne. Overall, the treatment is well tolerated and has shown promising results in improving skin condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Mitchel P Goldman, MD

Principal Investigator

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am in good health or have stable health conditions.

I am willing and able to give my consent and sign the HIPAA form.

I am willing to stop using facial treatments except for medical cleansers 14 days before the study starts, and stop all cleansers 1 week before.

Exclusion Criteria

Subject unlikely to comply with protocol

Breast feeding women

I haven't had facial treatments like peels or been in strong sunlight for 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photodynamic therapy (PDT) with BF-200 ALA and BF-RhodoLED® for moderate to severe acne vulgaris

8 weeks

Multiple visits for PDT sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Visits at 4 and 8 weeks post-treatment

Long-term monitoring

Participants are monitored for adverse events and changes in clinical parameters

up to 25 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BF-200 ALA (Ameluz®)

Trial Overview

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.

How Is the Trial Designed?

Group I: 3h incubation BF-200 ALA Experimental Treatment 1 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 ALA Experimental Treatment 1 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 vehicle Placebo Group 1 Intervention

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

Group IV: 1h incubation vehicle Placebo Group 1 Intervention

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

BF-200 ALA (Ameluz®) is already approved in European Union, United Kingdom, United States for the following indications:

Approved in European Union as Ameluz for:

• Actinic keratosis of mild to moderate intensity on the face and scalp
• Actinic keratosis on extremities and trunk/neck

Approved in United Kingdom as Ameluz for:

• Actinic keratosis of mild to moderate intensity on the face and scalp
• Actinic keratosis on extremities and trunk/neck

Approved in United States as Ameluz for:

• Actinic keratosis of mild to moderate severity on the face and scalp

Who Is Running the Clinical Trial?

Biofrontera Inc.

Lead Sponsor

Biofrontera Bioscience GmbH

Lead Sponsor

Trials

12

Recruited

1,900+

Published Research Related to This Trial

In a study of 243 patients, photodynamic therapy (PDT) using 20% aminolevulinic acid (ALA) and blue light resulted in a high efficacy rate, with 77% of patients achieving significant lesion clearing by week 8 and 89% by week 12, compared to only 18% and 13% in the placebo group.

The treatment was generally safe, with most side effects like erythema and edema resolving within 1 to 4 weeks, indicating that ALA PDT is a viable option for treating multiple actinic keratoses on the face and scalp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3, multicenter trials. Piacquadio, DJ., Chen, DM., Farber, HF., et al.[2013]

BF-200 ALA, a new gel formulation of 5-aminolaevulinic acid, demonstrated a significantly higher complete clearance rate for actinic keratosis (AK) lesions compared to placebo (78.2% vs. 17.1%) and was also more effective than the registered methyl-5-aminolaevulinate (MAL) cream (78.2% vs. 64.2%) in a study involving 600 patients.

The study highlighted that BF-200 ALA is a well-tolerated treatment option for AK, with varying efficacy and adverse events depending on the type of light source used during photodynamic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo. Dirschka, T., Radny, P., Dominicus, R., et al.[2016]

Topical aminolevulinic acid (ALA) photodynamic therapy (PDT) was tested in a small study involving 26 patients with conditions like acne, photoaging, and vitiligo, showing promising results after three to four treatments.

The treatment was applied at very low strengths (1-2%) over large areas, and side effects were minimal and self-limited, indicating a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy with low-strength ALA, repeated applications and short contact periods (40-60 minutes) in acne, photoaging and vitiligo. Serrano, G., Lorente, M., Reyes, M., et al.[2021]

5-aminolaevulinic acid (Ameluz) has been authorized for use in the European Union to treat mild to moderate actinic keratosis on the face and scalp, based on its effectiveness in improving the complete response rate of lesions.

The treatment involves applying the gel to the lesions and surrounding area, followed by illumination with red light, which activates a compound that destroys the target cells; common side effects include local reactions at the application site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: summary of the scientific assessment of the Committee for Medicinal Products for Human Use. Tzogani, K., Straube, M., Hoppe, U., et al.[2018]

Photodynamic therapy (PDT) using BF-200 ALA demonstrated high long-term efficacy in treating actinic keratosis (AK), with 47% of patients remaining completely clear of lesions for at least 12 months after treatment, compared to 36% for the methyl aminolaevulinate (MAL) cream.

The recurrence rates for BF-200 ALA were lower than those for MAL, particularly in patients treated with narrow wavelength LED lamps, indicating that BF-200 ALA may offer a superior treatment outcome without any reported safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis. Dirschka, T., Radny, P., Dominicus, R., et al.[2021]

Topical aminolevulinic acid combined with red light therapy effectively treats acne vulgaris, showing significant clinical improvement for at least 20 weeks after multiple treatments, and 10 weeks after a single treatment, in a study involving 22 subjects.

The treatment leads to prolonged suppression of sebum production and a decrease in follicular bacteria, although it is associated with side effects like transient hyperpigmentation and superficial exfoliation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical ALA-photodynamic therapy for the treatment of acne vulgaris. Hongcharu, W., Taylor, CR., Chang, Y., et al.[2013]

Photodynamic therapy using BF-200 ALA resulted in significantly higher complete clearance rates for actinic keratosis lesions compared to methyl-5-aminolevulinate (MAL), with a 9% better chance of clearance at 3 months.

BF-200 ALA also showed a 24% higher chance of clearing grade II-III lesions and a lower recurrence rate at 12 months compared to MAL, indicating its superior efficacy in treating more severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of photodynamic therapy with amino-5-laevulinate nanoemulsion versus methyl-5-aminolaevulinate for actinic keratosis: A meta-analysis. Fu, C., Kuang, BH., Qin, L., et al.[2021]

Photodynamic therapy with liposome-encapsulated 0.5% 5-ALA resulted in a significant 43.2% reduction in acne severity among 13 Korean subjects, demonstrating its efficacy in treating inflammatory acne.

The treatment was well-tolerated with no serious adverse events reported, indicating a favorable safety profile, especially important given the previous risks associated with higher concentrations of ALA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

0.5% Liposome-encapsulated 5-aminolevulinic acid (ALA) photodynamic therapy for acne treatment. An, JS., Kim, JE., Lee, DH., et al.[2018]

In a study involving 122 patients with actinic keratosis, photodynamic therapy (PDT) using the new stable formulation BF-200 ALA showed a significantly higher complete clearance rate of lesions (81%) compared to placebo (22%), demonstrating its efficacy in treating this condition.

The effectiveness of BF-200 ALA in PDT was influenced by the type of light source used, with the Aktilite CL128 achieving a remarkable 96% patient clearance rate, indicating that both the drug formulation and light characteristics are crucial for optimal treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study. Szeimies, RM., Radny, P., Sebastian, M., et al.[2013]

In a study involving 8 patients with moderate-to-severe acne, the use of the photosensitizer 5-aminolevulinic acid (ALA) combined with a 532 nm laser resulted in a 52% improvement in acne on the treated side compared to a 32% improvement on the untreated side.

Overall, the average acne grading improved from 3.20 to 2.12 over 12 weeks, indicating that ALA combined with light therapy is a promising alternative to traditional acne treatments, though further research is needed to optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label, split-face study comparing the safety and efficacy of levulan kerastick (aminolevulonic acid) plus a 532 nm KTP laser to a 532 nm KTP laser alone for the treatment of moderate facial acne. Sadick, N.[2013]

A study involving 247 acne patients revealed that over 97% experienced significant impacts on their quality of life due to acne, with 37.6% showing varying degrees of anxiety, highlighting the psychological effects of the condition.

Photodynamic therapy with topical 5-aminolevulinic acid (ALA-PDT) demonstrated efficacy rates of 59.4% to 85.7% in reducing acne severity after 3-4 treatment sessions, with adverse reactions being temporary and tolerable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The assessment of psychology, quality of life in acne patients and evaluation of ALA-PDT for moderate to severe acne. Zhang, Y., Wu, H., Tu, C., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11084902/

Long-Term Improvement of Different Types of Acne ...

In this study, we show that PDT with BF-200 ALA gel and low light dose is an effective and long-lasting option for the treatment of different acne types.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05080764

Study to Evaluate the Safety and Efficacy of BF-200 ALA ...

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®

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jaad.org

jaad.org/article/S0190-9622(21)00575-2/fulltext

Red light photodynamic therapy with BF-200 ALA showed ...

Treatment with BF-200 ALA and red light photodynamic therapy was well tolerated and yielded positive responses, with 86% of lesions cleared.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8711613/

Photodynamic Therapy with 5-aminolevulinic Acid 10% Gel ...

Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective randomized, double-blind, placebo-controlled phase III ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1572100025001929

Topical 5-aminolevulinic acid photodynamic therapy for ...

Results. Cheek elasticity significantly improved at weeks 4th and 8th (p = 0.006 and 0.002, respectively). Cheek hydration significantly increased at the 4th ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34976292/

Photodynamic Therapy with 5-aminolevulinic Acid 10% Gel ...

This article provides expert practical guidance for the use of the newest 5-aminolevulinic acid (ALA) product (ALA 10% gel) plus red light as monotherapy for ...

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jcadonline.com

jcadonline.com/photodynamic-therapy-with-5-aminolevulinic-acid-acne-actinic-keratosis-nonmelanoma/

Photodynamic Therapy with 5-aminolevulinic Acid 10% Gel ...

Adverse events associated with ALA-PDT for acne may include moderate-to-severe pain, acneiform eruptions (starting about 2 days after treatment and lasting ...