Portable Measurement of Protoporphyrin IX in the Skin During Photodynamic Therapy
Status:
Not yet recruiting
Trial end date:
2022-03-30
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Treatments:
Aminolevulinic Acid Levulinic acid Protoporphyrin IX