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Photosensitizer

Protoporphyrin IX Measurement for Photodynamic Therapy

N/A

Waitlist Available

Led By Michael S Chapman, MD, MBA

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Adults unable to consent

Individuals who are not yet adults

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to measure how well a skin cancer treatment is working. They will apply a drug to people's skin and then use a new device to measure how much of the drug is absorbed. They will also measure the person's skin temperature and skin type to see if these factors affect how well the drug is absorbed.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an observational study focusing on measurement rather than treatment, direct side effects from the interventions are not applicable. However, typical PDT side effects may include skin irritation and sensitivity to light.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent for myself.

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I am under the age of 18.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Protoporphyrin IX levels on the skin

Secondary study objectives

Effect of Fitzpatrick skin type (skin pigmentation) on change in protoporphyrin IX levels

Effect of age on change in protoporphyrin IX levels at baseline and at serial time points after Ameluz application (the intervention)

Effect of diet on change in protoporphyrin IX levels

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Ameluz (amino-levulinic acid topical gel) OnlyActive Control2 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 TherapyActive Control3 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.

0 / 2Eligibility criteria met