Portable Measurement of Protoporphyrin IX in the Skin During Photodynamic Therapy

• Status: Not yet recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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, they have never been done in a clinical setting. With the development of a new handheld, smart phone-associated device to measure PpIX, this measurement is now feasible. This is a prospective single center quantitative descriptive study in which the investigators will be applying the prodrug ALA on various parts of a person's body and then taking measurements PpIX at various time points. This will then be correlated with the individuals age, skin temperature, and skin type. The investigators hypothesize that the concentration 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 using Mat-lab. The investigators will assess for how anatomical location, skin pigmentation, skin temperature, and other factors influence PpIX concentration. PpIX levels will be measured quantitatively using our newly developed PpIX smart phone device at 0, 30, 45, and 60 min after ALA application. Skin temperature will also be measured at these time points using and infrared (IR) camera. Fitzpatrick skin type will be assessed by the provider to assess skin pigmentation. All of these factors will be correlated to the PpIX concentration in 5 anatomical locations (forehead, cheeks, forearms, hands, and bald scalp where applicable) to determine which factors most greatly influence the concentration of PpIX.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Aminolevulinic Acid; Levulinic acid; Protoporphyrin IX

Criteria

Inclusion Criteria:

• All patients appearing at the Dartmouth-Hitchcock Medical Center Heater Road Dermatology Clinic for photodynamic therapy treatment

• All other patients at Dartmouth-Hitchcock Medical Center Heater Road Dermatology clinic without a current prescription for photodynamic therapy.

Exclusion Criteria:

• Pregnant women

• Women who are breast-feeding

• Adults unable to consent

• Individuals who are not yet adults

• Prisoners.

• Any participants with a condition that makes them not suitable for clinical photodynamic therapy.