CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 219 enrolled
Drug / intervention
Portable Apple Smart Phone Protoporphyrin IX Spectrometer Cameradevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04223570
NCT04223570N/ACompleted

Portable Measurement of Protoporphyrin IX in the Skin

Dartmouth-Hitchcock Medical Center·observational·Posted Jan 10, 2020·Updated Nov 21, 2025

In Brief

An observational study evaluating Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera for Photodynamic Therapy and Protoporphyrin IX. Completed, enrolled 219 participants across 1 site.

Detailed 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, 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 10, 2020
Enrollment StartDec 1, 2022
Primary CompletionMay 20, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.5 years ago

Interventions

Portable Apple Smart Phone Protoporphyrin IX Spectrometer Cameradevice

This is a portable device that uses a camera to non-invasively and efficiently measure the level of protoporphyrin IX in various areas skin. This camera will be used in all participants to measure the level of protoporphyrin IX in various areas of skin as detailed in the study description.