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NCT04223570 · ClinicalTrials.gov registry record

Portable Measurement of Protoporphyrin IX in the Skin

A clinical trial, sponsored by Dartmouth-Hitchcock Medical Center.

Completed
Registry status
219
Enrollment target

NCT04223570: Completed study, sponsored by Dartmouth-Hitchcock Medical Center.

NCT04223570 is a clinical trial that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 219 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04223570 has completed, sponsored by Dartmouth-Hitchcock Medical Center.

COMPLETED
Registry status
219 participants
Enrollment target

Study 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.

Primary Outcome

Measure change in protoporphyrin IX levels in the skin of the forehead, malar cheek, dorsal hand, and dorsal forearm patients, as well as the bald scalp in male patients

Interventions

  • DEVICE Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera

Trial Details

FieldValue
Enrollment Target 219 participants
Start Date 2022-12-01
Est. Completion 2025-05-20
Dartmouth-Hitchcock Medical Center

427 total trials

What the finished NCT04223570 record still lists

NCT04223570 is an observational study that tracks outcomes without assigning an intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera is the first listed.

NCT04223570 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04223570 about?

NCT04223570 is a clinical study titled "Portable Measurement of Protoporphyrin IX in the Skin". 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 aci...

What is the current status of trial NCT04223570?

This trial is currently completed. The enrollment target is 219 participants. The study started on 2022-12-01. Estimated completion is 2025-05-20.

What interventions are being tested in trial NCT04223570?

The interventions under investigation include: Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera (DEVICE).

Who is sponsoring clinical trial NCT04223570?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04223570, the US trial registry maintained by the National Library of Medicine. NCT04223570 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.