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 — DRUG
    One-time topical application of 10% Ameluz gel for up to 1 hour
  • Protoporphyrin IX — DEVICE
    Tissue 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

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth HitchcockLebanonNew Hampshire03766
Dylan Parker, MD
6036532209

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