Protoporphyrin IX Measurement for Photodynamic Therapy

Overseen By Keegan O'Hern, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Pregnancy, Breast-feeding, Minors, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve photodynamic therapy (PDT) for treating skin conditions such as actinic keratosis and non-melanoma skin cancers. Researchers are testing a new device that measures the level of the drug metabolite Protoporphyrin IX (PpIX) in the skin, which could help customize PDT treatments. The trial will explore how factors like skin type and diet affect PpIX levels. Participants may receive either a topical gel called Ameluz (used in PDT) alone or with additional light therapy. People visiting the Dartmouth-Hitchcock Medical Center Dermatology Clinic who have not been prescribed PDT might be suitable candidates for this trial.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancements in skin condition therapies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for measuring PpIX levels?

Research has shown that Ameluz, a gel used in light therapy for skin treatments, is generally safe. Most side effects occur during or immediately after the light treatment. These effects are typically mild or moderate, lasting from 1 to 4 days. Common reactions include redness, pain, burning, irritation, and swelling at the application site. However, some individuals might temporarily experience memory loss or confusion, so informing a doctor if this occurs is important. Overall, Ameluz is well-tolerated when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of Ameluz for photodynamic therapy because it explores the potential to enhance skin treatment precision by measuring Protoporphyrin IX (PpIX) levels. Unlike traditional treatments for actinic keratoses, which often involve physical removal or freezing of lesions, Ameluz is a topical gel that activates with light to target abnormal skin cells. This trial aims to refine how we monitor PpIX in the skin, potentially leading to more effective and targeted photodynamic therapy with fewer side effects.

What evidence suggests that this device is effective for measuring Protoporphyrin IX levels?

Research has shown that Ameluz, a gel applied to the skin, effectively treats skin conditions like actinic keratosis (AK). One study found that 97.1% of skin spots treated with the gel improved significantly by Day 84. This trial will include participants receiving Ameluz alone and those receiving Ameluz with photodynamic therapy (PDT) using a special light. Another study found that PDT with Ameluz also improves skin moisture and flexibility, making it useful for skin rejuvenation. When combined with a special red light, the treatment resulted in good cosmetic outcomes, with most cases rated as very good or good. These findings support Ameluz's effectiveness in treating surface-level skin issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael S Chapman, MD MBA

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 visiting the Dartmouth-Hitchcock Medical Center Heater Road Dermatology Clinic. It's not open to prisoners, pregnant or breastfeeding women, those unable to consent, and minors.

Inclusion Criteria

I am 18 or older and visiting the Dartmouth-Hitchcock Dermatology Clinic.

Exclusion Criteria

I am unable to give consent for myself.

Pregnant women

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Initial measurement of Protoporphyrin IX levels in various skin locations

1 day

1 visit (in-person)

Ameluz Application

Application of Ameluz gel to measure PpIX levels in different skin areas

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in PpIX levels and other factors

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ameluz
• Photodynamic Therapy Light
• Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera

Trial Overview The study tests a new portable device using an Apple smartphone that measures Protoporphyrin IX levels in the skin after applying a photosensitizing drug used in photodynamic therapy for skin lesions.

How Is the Trial Designed?

Group I: Ameluz (amino-levulinic acid topical gel) Only Active Control 2 Interventions

Ameluz is a topical gel approved for use in photodynamic therapy for treatment of actinic keratoses, among other skin conditions. It is being applied to all participants in this study to measure the levels of PpIX in different areas of skin as detailed in study description. This arm includes those participants who have not been prescribed photodynamic therapy and thus they will not receive any light treatment during this study.

Group II: Ameluz and Light Therapy Active Control 3 Interventions

Ameluz is a topical gel approved for use in photodynamic therapy for treatment of actinic keratoses, among other skin conditions. It is being applied to all participants in this study to measure the levels of PpIX in different areas of skin as detailed in study description. For patients who have been prescribed photodynamic therapy, the investigators will perform one additional round of measurements of Protoporphyrin IX using our camera device, in addition to the other secondary outcomes including skin temperature.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6440706/

Safety and Efficacy of Aminolevulinic Acid 10% Topical Gel ... Results: Lesions treated with GEL were 97.1 percent cleared at Day 84 versus 94.9 percent for lesions treated with SOL (p<0.001 vs. baseline); ...

2. ameluz.com ameluz.com/hcp/why-ameluz

Demonstrated efficacy – AMELUZ® and BF-RhodoLED® See the results of AMELUZ® and the BF-RhodoLED® lamp on patients with mild-to-moderate AK lesions on the face and scalp from a phase 3 clinical trial.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1572100024003983

High efficacy of red light photodynamic therapy with 10 % ... Our results suggest that red light PDT with 10% ALA gel is an effective treatment option for AK regardless of the extent of keratinocyte atypia.

4. jaad.org jaad.org/article/S0190-9622(25)02656-8/fulltext

Red light photodynamic therapy with 10% aminolevulinic ... For most lesions (89.3%) treated with 10% ALA gel, the investigators rated the esthetic outcome as very good or good. In contrast, investigators ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04319159

Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for ... The aim of this study is to assess the pharmacokinetics (PK) of the parent drug 5-aminolevulinic acid (ALA) and its active metabolite protoporphyrin IX ...

6. us.ameluz.com us.ameluz.com/important-safety-information

Important Safety Information Patients Most side effects occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases.

7. us.ameluz.com us.ameluz.com/hcp/important-safety-information

Important Safety Information HCP AMELUZ®, containing 10% aminolevulinic acid hydrochloride, is a non-sterile gel formulation for topical use only. Not for ophthalmic, oral, or intravaginal use.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/208081s002lbl.pdf

4148813 This label may not be the latest approved by FDA ... AMELUZ is for topical use only (2.1). • Photodynamic therapy with AMELUZ involves preparation of lesions, application of the product, occlusion and illumination.

9. mayoclinic.org mayoclinic.org/drugs-supplements/aminolevulinic-acid-topical-route/description/drg-20061659

Aminolevulinic acid (topical route) - Side effects & uses This medicine can cause episodes of temporary memory loss. Check with your doctor right away if you have problems with your memory, confusion, ...

10. us.ameluz.com us.ameluz.com/hcp/why-ameluz/safety-profile

Safety Profile – AMELUZ® and BF-RhodoLED® The most frequent adverse reactions (≥10%) during and after PDT were application site erythema, pain, burning, irritation, edema, pruritus, exfoliation, scab, ...