Ameluz + BBL HEROic for Actinic Keratosis

Overseen By Catherine VanHooft, BA, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sherrif Ibrahim

Must not be taking: Topical treatments, Cancer treatments

Disqualifiers: Pregnancy, Photosensitivity diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to discover a new treatment for actinic keratoses (rough, scaly patches on the skin from sun exposure) and signs of skin aging from sun damage, such as dark spots and wrinkles. The treatment uses Ameluz (a topical gel) combined with a special light therapy called BBL HEROic. Individuals with visible sun damage and actinic keratoses on their face may be suitable candidates. Participants will undergo two rounds of this therapy to evaluate its effectiveness. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

If you are using any topical treatments for actinic keratoses, you must stop at least one month before joining the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that this treatment is safe for actinic keratosis and photodamage?

Research has shown that Ameluz, when used in photodynamic therapy (PDT), is generally easy for patients to handle. In studies involving individuals with mild-to-moderate sun damage on their face and scalp, Ameluz effectively cleared the skin. Specifically, 78.2% of patients had completely clear skin 12 weeks after treatment, indicating its effectiveness.

Safety remains a major concern. One study found that Ameluz was well-tolerated, with no serious safety issues reported. Patients experienced no significant side effects during treatment, suggesting it is safe for use. Multiple studies support this finding.

While Ameluz is being tested for this specific treatment, it has already received approval for other uses, providing some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Ameluz combined with BBL HERO for treating actinic keratosis because it brings a new twist to photodynamic therapy (PDT). While traditional treatments like cryotherapy and topical creams are common, this approach uses Ameluz to sensitize the skin, making it more receptive to the light from the HEROic BBL device. This combination potentially enhances the treatment's effectiveness against both actinic keratosis and signs of photodamage, offering a more comprehensive solution. Additionally, this method may reduce the number of sessions needed compared to current standards, which is an appealing prospect for patients seeking quicker results.

What evidence suggests that this treatment might be an effective treatment for actinic keratosis?

Research has shown that Ameluz, when used in photodynamic therapy (PDT), effectively treats actinic keratosis (AK), which are rough, scaly patches on the skin caused by sun damage. One study found that 78.2% of patients had all their AK spots cleared 12 weeks after using Ameluz. Another study reported individual clearance rates ranging from 66.7% to 100% for patients. These findings suggest that Ameluz is a strong option for clearing these skin spots. Additionally, the treatment is generally well-tolerated, meaning it doesn't cause severe side effects for most people. Participants in this trial will receive two PDT treatments using Ameluz and HEROic BBL to treat facial AK and signs of photodamage. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with visible and palpable signs of actinic keratoses (mild to moderate) and photodamage on the face, including dyspigmentation, solar lentigines, telangiectasias, erythema, roughness, fine lines, wrinkles, and actinic bronzing. Pregnant individuals or those trying to conceive are excluded as well as those sensitive to study materials or undergoing cancer treatment.

Inclusion Criteria

Willingness to participate in all required study activities and visits

Willingness to sign the informed consent form

I am over 18 years old.

Exclusion Criteria

Subject who is pregnant or trying to become pregnant during the study

Subjects with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material

I cannot or do not want to agree to the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial actinic keratoses and signs of photodamage

4 weeks

Follow-up

Participants are monitored for cosmetic outcomes and percentage of actinic keratosis lesion clearance

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ameluz

Trial Overview

The trial tests a combined treatment using Sciton HEROic light activation and Ameluz medication for treating both actinic keratoses and overall sun damage on the skin. The goal is to address multiple symptoms of photodamage in one go.

How Is the Trial Designed?

Group I: Two PDT treatments Experimental Treatment 2 Interventions

Each subject will receive 2 treatments of photodynamic therapy using Ameluz and HEROic BBL to treat facial AK and signs of photodamage.

Who Is Running the Clinical Trial?

Sherrif Ibrahim

Lead Sponsor

Trials

1

Recruited

10+

Sciton

Industry Sponsor

Trials

20

Recruited

1,400+

Biofrontera Bioscience GmbH

Industry Sponsor

Trials

12

Recruited

1,900+

Citations

1.

ameluz.co.uk

ameluz.co.uk/treatment/ameluz/study-data

Study data - Ameluz®

Results: Complete patient clearance 12 weeks after the last PDT (primary endpoint) was 78.2% for Ameluz, 64.2% for MAL cream and 17.1% for placebo. Ameluz was ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6585804/

A randomized, intraindividual, non‐inferiority, Phase III ...

Daylight PDT of AK with BF‐200 ALA is well‐tolerated and non‐inferior to MAL/dPDT. The study demonstrates a trend towards higher efficacies after 3 months.

3.

ameluz.com

ameluz.com/hcp/why-ameluz

Demonstrated efficacy – AMELUZ® and BF-RhodoLED®

Results from a pivotal clinical trial with 87 patients presenting 4 to 8 mild-to-moderate AK lesions on the face/forehead and/or bald scalp treated with AMELUZ® ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1572100021005093

Photodiagnosis and Photodynamic Therapy

In this study, field-directed SDL-PDT improved disease burden in all patients, with 66.7–100.0% individual clearance rates and 84.9% overall lesion clearance ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jdv.20452

Long‐term follow‐up of a randomized, double‐blind, phase ...

Photodynamic therapy (PDT) is an effective field-directed treatment option for AK; however, long-term efficacy data are still scarce. Objectives.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05060237

Study to Evaluate Safety and Tolerability of BF-200 ALA ...

The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the ...