BF-200 ALA + PDT for Actinic Keratosis

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen by Nathalie Zeitouni, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Biofrontera Bioscience GmbH

Must not be taking: Immunosuppressants, Cytostatics, Glucocorticosteroids, others

Disqualifiers: Hypersensitivity to ALA, Porphyria, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but certain medications must be stopped before joining. You cannot use specific topical treatments within 3 months or certain systemic treatments within 6 to 12 weeks before screening. Check with the trial team for details on your specific medications.

What data supports the effectiveness of the treatment BF-200 ALA + PDT for actinic keratosis?

Research shows that photodynamic therapy (PDT) with BF-200 ALA, a gel formulation of 5-aminolevulinic acid (ALA), has high clearance rates for mild-to-moderate actinic keratosis (AK) and is more effective than a similar treatment using methyl aminolaevulinate (MAL) cream. ^{1 2 3 4 5}

Is BF-200 ALA + PDT safe for humans?

Photodynamic therapy (PDT) with BF-200 ALA has been shown to be a safe treatment option for actinic keratosis, a skin condition, in several studies. It is generally well-tolerated in humans, with no major safety concerns reported. ^{1 2 4 6 7}

What makes BF-200 ALA + PDT unique for treating actinic keratosis?

BF-200 ALA + PDT is unique because it uses a nanoemulsion gel formulation of 5-aminolevulinic acid (ALA) that improves skin penetration and stability, leading to higher clearance rates of actinic keratosis compared to other treatments like methyl aminolaevulinate (MAL) cream. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for adults with 4-15 mild to moderate Actinic Keratosis lesions on extremities or neck/trunk. Participants must be in good health, not use tanning beds, and agree to a biopsy if needed. Women of childbearing age must have a negative pregnancy test and use contraception.

Inclusion Criteria

I have 4-15 mild to moderate skin lesions on my arms, legs, neck, or trunk.

Women who can have babies need to have a negative pregnancy test.

I am willing to stop using skin products in the treatment area 24 hours before my next visit.

Exclusion Criteria

Receipt of any investigational drug or medical product within 8 weeks before screening or simultaneous participation in another clinical study

I do not have any health issues that would make it hard to follow the study or affect my safety.

I do not have sunburn or skin conditions near the treatment area.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Treatment

Participants receive photodynamic therapy (PDT) with BF-200 ALA or vehicle treatment

16-28 weeks

Multiple visits (in-person) depending on treatment schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

2 visits (in-person) at 6 and 12 months after last PDT

Treatment Details

Interventions

• BF-200 ALA (Ameluz®) (Photosensitizer)
• Photodynamic Therapy with Red Light LED Lamp (Procedure)

Trial Overview The study tests the safety and effectiveness of BF-200 ALA gel with RhodoLED lamp light therapy versus a placebo treatment for Actinic Keratosis. Patients will receive up to two treatments within about 12 weeks.

Participant Groups

Group I: 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)

Group II: Vehicle Placebo Group 1 Intervention

Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Skin Search of Rochester, Inc. Rochester, NY

Clinical Research Center of the Carolinas Charleston, SC

Rochester Dermatologic Surgery Victor, NY

DermResearch, P.A. Austin, TX

More Trial Locations

Who Is Running the Clinical Trial?

Biofrontera Bioscience GmbH Lead Sponsor

References

1. England 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. [2016] Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) or its methylester [methyl-5-aminolaevulinate (MAL) or 5-amino-4-oxopentanoate] was recently ranked as first-line therapy for the treatment of actinic keratosis (AK) and is an accepted therapeutic option for the treatment of neoplastic skin diseases. BF-200 ALA (Biofrontera Bioscience GmbH, Leverkusen, Germany) is a gel formulation of ALA with nanoemulsion for the treatment of AK which overcomes previous problems of ALA instability and improves skin penetration.

2. England 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. [2021] Two phase III trials of photodynamic therapy (PDT) with BF-200 ALA, a recently approved nanoemulsion formulation of 5-aminolaevulinic acid (ALA) demonstrated high clearance rates in mild-to-moderate actinic keratosis (AK). The comparison to a registered methyl aminolaevulinate (MAL) cream demonstrated significantly superior total patient clearance rates.

3. France pubmed.ncbi.nlm.nih.gov

A controlled trial of photodynamic therapy of actinic keratosis comparing different red light sources. [2014] Photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA) with red light is well established for actinic keratosis (AK). Differences have been observed concerning pain and efficacy rates with different red light sources.

4. England pubmed.ncbi.nlm.nih.gov

In vitro and in vivo comparison of two different light sources for topical photodynamic therapy. [2013] Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) is an effective and safe treatment option for the treatment of actinic keratosis (AK). Incoherent lamps are often used, matching the absorption maxima of ALA.

5. United States 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. [2021] Topical aminolevulinic acid (ALA) photodynamic therapy (PDT) is currently being used for the treatment of actinic keratosis of the face and scalp. This study reports the results obtained after three to four treatments with ALA-PDT in patients with acne (n=12), photoaging (n=8) and vitiligo (n=6). ALA was applied on large areas (e.g., full face) and at very low strengths (1-2%). Side effects were minimal and self-limited.

6. United States 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. [2013] To determine the safety and efficacy of photodynamic therapy (PDT) using 20% wt/vol aminolevulinic acid hydrochloride (hereinafter "ALA") and visible blue light for the treatment of multiple actinic keratoses of the face and scalp.

7. United States pubmed.ncbi.nlm.nih.gov

A multicenter, randomized, vehicle-controlled phase 2 study of blue light photodynamic therapy with aminolevulinic acid HCl 20% topical solution for the treatment of actinic keratoses on the upper extremities: the effect of occlusion during the drug incubation period. [2013] Photodynamic therapy (PDT) with aminolevulinic acid (ALA) has been shown to be safe and effective in the treatment of actinic keratoses (AKs) of the face and scalp. A recent small study has suggested that ALA-PDT can be effective for AKs of the dorsal hands/forearms. However, studies designed to provide sufficient statistical power to test this hypothesis are lacking in the literature.

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of 3 different light doses in the treatment of actinic keratosis with 5-aminolevulinic acid photodynamic therapy: a randomized, observer-blinded, intrapatient, comparison study. [2013] Topical 5-aminolevulinic acid-based photodynamic therapy (ALA-PDT) has been established in recent years as an effective treatment for disseminated actinic keratosis (AK). As yet, however, data are lacking to define the optimal light dose for activation of ALA-induced protoporphyrin IX in AK.