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

218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Photodynamic therapy (PDT) is increasingly used to treat superficial skin lesions, such as actinic keratosis (AK) and non-melanoma skin cancers, and has been demonstrated to be an effective and safe alternative to surgery. It is performed by applying a photosensitizing pro-drug, amino -levulinic acid (ALA) and then allowing the conversion to the metabolite Protoporphyrin IX (PpIX). While attempts to measure the concentration of this drug in the skin have been performed before, there remains limited research on an individuals' baseline level of PpIX which could lead to the customization of PDT. With the development of a new handheld, smart phone-associated device to measure red fluoresce intensity of PpIX, this measurement is now feasible. This is an observational single center quantitative study in which the investigators will take measurements of red fluoresce intensity of PpIX at various locations. This will then be correlated with the individuals age, oral temperature, diet, and skin type. The investigators hypothesize that the levels of PpIX will depend on all of these factors, including anatomical location. All data will be collected into the data collection form and then analyzed. The investigators will assess for how anatomical location, skin pigmentation, oral temperature, and other factors influence PpIX levels. Fitzpatrick skin type will be assessed by the provider to assess skin pigmentation. All of these factors will be correlated to the PpIX levels in 5 anatomical locations (forehead, cheeks, forearms, hands, and bald scalp where applicable) to determine which factors most greatly influence the red fluoresce intensity of PpIX.

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+