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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 is a clinical trial that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 219 participants.
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.
Interventions
- DEVICE Portable Apple Smart Phone Protoporphyrin IX Spectrometer Camera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2022-12-01 |
| Est. Completion | 2025-05-20 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04223570
The ClinicalTrials.gov registry entry for NCT04223570 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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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