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
Part of paid clinical trials in Lebanon, New Hampshire.
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Study ID
- NCT07201376
- Status
- Recruiting
Conditions
- Benign Skin Growth
- Non-Melanoma Skin Cancer (NMSC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Ameluz 10% Topical Gel — DRUGOne-time topical application of 10% Ameluz gel for up to 1 hour
- Protoporphyrin IX — DEVICETissue oxygen imaging using protoporphyrin IX (PIX), a non-significant risk device.
Study Details
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).
Key Dates
- Start date
- Nov 14, 2025
- Status verified
- Sep 2025
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 125 participants (estimated)
Primary Outcome Measure
Detecting cutaneous malignant lesions using a non-invasive technique [ Time Frame: Six months after the first enrollment ]
Central Contacts
- Dylan L Parker, MD603-653-2209
- Staci Shaw603-650-3693
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dartmouth Hitchcock | Lebanon | New Hampshire | 03766 |
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