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
Dartmouth-Hitchcock Medical Center · with Dartmouth College · NCT07201376
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 125
- US sites recruiting
- 1
- Study start
- November 14, 2025
- Record last updated
- February 6, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Ameluz 10% Topical Gel; Protoporphyrin IX
Conditions: Non-Melanoma Skin Cancer (NMSC); Benign Skin Growth
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Adults ≥ 18 years of age.
- Histologic proof of non-melanoma skin cancer. Patients with different skin tones based on the Fitzpatrick Scale, who present with skin growth or lesions and are scheduled for resection.
- As determined by the enrolling physician or study team member, the patient must have the willingness and ability to understand and comply with study procedures.
- Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12-months and capable to become pregnant, must have a negative serum beta-HCG pregnancy test result within seven days prior to start of study.
- Lesions must measure between 5 mm and 3 cm in diameter.
Exclusion Criteria
- Patients who are \<18 years of age
- Adults who are unable to provide informed consent.
- Known allergy to Ameluz
- Photosensitivity or photodermatoses or similar conditions.
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol, in the opinion of the investigator
- Known hypersensitivity to porphyrins or to any component of Ameluz, including soya bean phosphatidylcholine.
- Females who are currently breast-feeding
Recruiting US locations
Dartmouth Hitchcock
Lebanon, NH 03766
Site contact: Dylan Parker, MD · 6036532209 · Dylan.J.Parker@Hitchcock.org
Study contacts (from the official record)
- Dylan L Parker, MD · 603-653-2209 · Dylan.J.Parker@Hitchcock.org
- Staci Shaw · 603-650-3693 · Staci.L.Shaw@Hitchcock.org
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