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Photosensitizer

Protoporphyrin IX Measurement for Photodynamic Therapy

Phase < 1
Waitlist Available
Led By Michael S Chapman, MD, MBA
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients and staff appearing at the Dartmouth-Hitchcock Medical Center Heater Road Dermatology Clinic who are aged 18 years and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights

Study Summary

This trial is testing a new way to measure how well a skin cancer treatment is working. They will apply a drug to people's skin and then use a new device to measure how much of the drug is absorbed. They will also measure the person's skin temperature and skin type to see if these factors affect how well the drug is absorbed.

Who is the study for?
This trial is for adults over 18 visiting the Dartmouth-Hitchcock Medical Center Heater Road Dermatology Clinic. It's not open to prisoners, pregnant or breastfeeding women, those unable to consent, and minors.Check my eligibility
What is being tested?
The study tests a new portable device using an Apple smartphone that measures Protoporphyrin IX levels in the skin after applying a photosensitizing drug used in photodynamic therapy for skin lesions.See study design
What are the potential side effects?
Since this is an observational study focusing on measurement rather than treatment, direct side effects from the interventions are not applicable. However, typical PDT side effects may include skin irritation and sensitivity to light.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and visiting the Dartmouth-Hitchcock Dermatology Clinic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Protoporphyrin IX levels on the skin
Secondary outcome measures
Effect of Fitzpatrick skin type (skin pigmentation) on change in protoporphyrin IX levels
Effect of age on change in protoporphyrin IX levels at baseline and at serial time points after Ameluz application (the intervention)
Effect of diet on change in protoporphyrin IX levels
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Ameluz (amino-levulinic acid topical gel) OnlyActive Control2 Interventions
Ameluz is a topical gel approved for use in photodynamic therapy for treatment of actinic keratoses, among other skin conditions. It is being applied to all participants in this study to measure the levels of PpIX in different areas of skin as detailed in study description. This arm includes those participants who have not been prescribed photodynamic therapy and thus they will not receive any light treatment during this study.
Group II: Ameluz and Light TherapyActive Control3 Interventions
Ameluz is a topical gel approved for use in photodynamic therapy for treatment of actinic keratoses, among other skin conditions. It is being applied to all participants in this study to measure the levels of PpIX in different areas of skin as detailed in study description. For patients who have been prescribed photodynamic therapy, the investigators will perform one additional round of measurements of Protoporphyrin IX using our camera device, in addition to the other secondary outcomes including skin temperature.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
521 Previous Clinical Trials
2,542,181 Total Patients Enrolled
Michael S Chapman, MD, MBAPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

Ameluz (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT04223570 — Phase < 1
Photodynamic Therapy Research Study Groups: Ameluz (amino-levulinic acid topical gel) Only, Ameluz and Light Therapy
Photodynamic Therapy Clinical Trial 2023: Ameluz Highlights & Side Effects. Trial Name: NCT04223570 — Phase < 1
Ameluz (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04223570 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age of a potential participant affect their eligibility for this research study?

"Applicants who are between 18 and 75 years of age will be considered for participation in this clinical trial."

Answered by AI

What medical applications is Ameluz (amino-levulinic acid topical gel) typically employed in?

"Ameluz (amino-levulinic acid topical gel) is typically administered to treat scalp structure, but can also be deployed in the management of carcinoma, squamous cell carcinoma and facial lesions."

Answered by AI

Are there available slots for participants in this trial?

"According to clinicaltrials.gov, this medical study, first posted on December 1st 2022 is no longer actively recruiting patients. However, there are 41 other trials that require participants at this time."

Answered by AI

How many participants are capably being admitted into this research endeavor?

"This trial is not presently accepting applicants. It was initially uploaded on December 1st 2022 and last revised a few months later, on March 21st 2021. If you are searching for other trials, there are currently 23 clinical studies looking to recruit participants with photochemotherapy and 18 research initiatives focused on Ameluz (amino-levulinic acid topical gel). These programmes only welcome actively enrolling individuals."

Answered by AI

Has research surrounding the efficacy of Ameluz (amino-levulinic acid topical gel) been conducted independently?

"Currently, 18 studies are ongoing for Ameluz (amino-levulinic acid topical gel) Only. Out of these trials, 2 have reached Phase 3 status and they are all located in Lebanon, New hampshire. Nevertheless, 56 locations across the country host different clinical trials dedicated to this treatment."

Answered by AI

What criteria do participants need to meet in order to be accepted into this medical study?

"This trial is accepting 50 volunteers aged 18 to 75 who already receive photodynamic therapy treatment at Dartmouth-Hitchcock Medical Center Heater Road Dermatology Clinic. Furthermore, other individuals seen in the clinic without a prescription for this form of photochemotherapy are also eligible to participate."

Answered by AI
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~0 spots leftby Mar 2024