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Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically

NCT07201376 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2026-02-06

No results posted yet for this study

Summary

The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).

Conditions

  • Non-Melanoma Skin Cancer (NMSC)
  • Benign Skin Growth

Interventions

DRUG

Ameluz 10% Topical Gel

One-time topical application of 10% Ameluz gel for up to 1 hour

DEVICE

Protoporphyrin IX

Tissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.

Sponsors & Collaborators

  • Dartmouth College

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Michael Chapman, MD · Dartmouth

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2026-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201376 on ClinicalTrials.gov