CompletedPhase 1

Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)

United States20 participantsStarted 2012-03-12

Plain-language summary

GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin. SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and efficacy of PDT using 5-aminolevulinic acid (ALA) and 633 nm light in the treatment of benign dermal neurofibromas. Specifically, the primary goal of the current study is to determine the maximum tolerable light doses that can be administered to subjects undergoing topical photoillumination photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical Solution.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: 18 years or older.
. NF1 will be diagnosed by American Academy of Neurology guidelines.
. Location of tumor: cutaneous, trunk or limbs only.
. Tumor type: superficial dermal neurofibromas, less than or equal to 4 mm deep.
. Growth confirmation: direct measurement for the dermal neurofibromas, ruler and photo-volumetric method.
. Informed consent of subject.
. Absence of any other malignancy.
. Only failures to meet criteria 1-6 due to the primary disease will be disqualifying

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Photosensitizer Uptake and Conversion to Protoporphyrin IX

Timeframe: 24 hours

Part 2: Maximum Tolerated Dose (MTD) of 633 nm Red Light

Timeframe: 48 hours

Trial details

NCT IDNCT01682811

SponsorHarry T Whelan, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10-23

Results submitted2021-02-16

View on ClinicalTrials.gov More Neurofibromatoses trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: 18 years or older.
. NF1 will be diagnosed by American Academy of Neurology guidelines.
. Location of tumor: cutaneous, trunk or limbs only.
. Tumor type: superficial dermal neurofibromas, less than or equal to 4 mm deep.
. Growth confirmation: direct measurement for the dermal neurofibromas, ruler and photo-volumetric method.
. Informed consent of subject.
. Absence of any other malignancy.
. Only failures to meet criteria 1-6 due to the primary disease will be disqualifying

Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria