Protoporphyrin IX Measurement for Photodynamic Therapy
Trial Summary
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.
Research Team
Michael S Chapman, MD MBA
Principal Investigator
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Measurement
Initial measurement of Protoporphyrin IX levels in various skin locations
Ameluz Application
Application of Ameluz gel to measure PpIX levels in different skin areas
Follow-up
Participants are monitored for changes in PpIX levels and other factors
Treatment Details
Interventions
- Ameluz
- Photodynamic Therapy Light
- Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor