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Photosensitizer

Photodynamic Therapy for Neurofibromatosis

Phase 2
Recruiting
Research Sponsored by Donald Basel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed NF1, determined by American Academy of Neurology Guidelines
Patient is 14 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new treatment for neurofibromas in patients with NF1. The treatment involves using a light-activated drug (Levulan Kerastick) and red light to kill the neurofibromas. The investigators will measure how well the treatment works and how long it works for.

Who is the study for?
This trial is for individuals aged 14 or older with neurofibromatosis type 1 (NF1), specifically those with superficial skin tumors on the trunk or limbs. Participants must not have other cancers, be pregnant, have a life expectancy under three years, or be sensitive to light used in therapy. They should not have had recent chemotherapy and must agree to follow-up requirements.Check my eligibility
What is being tested?
The study tests Levulan Kerastick topical photosensitizer combined with red light photodynamic therapy (PDT) on benign skin tumors in NF1 patients. It aims to observe how long before the treated tumors progress compared to untreated ones and understand tumor growth rates.See study design
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site such as redness, pain, burning sensation, peeling or swelling. There might also be sensitivity to sunlight or artificial light sources like sunlamps.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with NF1 according to specific guidelines.
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I am 14 years old or older.
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My cancer is located on my skin, trunk, or limbs.
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My skin tumors are less than 4mm deep.
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I do not have any other type of cancer.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to disease progression
Secondary outcome measures
Tumor growth rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: PDT TreatmentExperimental Treatment1 Intervention
Each subject will have either placebo or Levulan Kerastick topical application applied to matched sets of neurofibromas. Each subject will have both sets, in order to serve as his/her own control subject. 16 to 24 hours post study drug treatment, both sets of neurofibromas, Levulan and placebo treated, will be irradiated with red light (630 nm) from an Omnilux Revive light device at 100 mW/cm2 for 1000 seconds (16.7 minutes).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aminolevulinic acid
1997
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

Donald BaselLead Sponsor
Harry T Whelan, MDLead Sponsor
3 Previous Clinical Trials
26 Total Patients Enrolled
Donald G Basel, MDStudy DirectorMedical College of Wisconsin

Media Library

Aminolevulinic Acid (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT02728388 — Phase 2
Neurofibromatosis Research Study Groups: PDT Treatment
Neurofibromatosis Clinical Trial 2023: Aminolevulinic Acid Highlights & Side Effects. Trial Name: NCT02728388 — Phase 2
Aminolevulinic Acid (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02728388 — Phase 2
Neurofibromatosis Patient Testimony for trial: Trial Name: NCT02728388 — Phase 2

Frequently Asked Questions

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

What is the traditional purpose of aminolevulinic acid in terms of medical treatment?

"Aminolevulinic acid may be utilized to address scalp structure, carcinoma and squamous cell carcinoma."

Answered by AI

What is the upper limit of individuals enrolled in this investigation?

"Affirmative. Clinicaltrials.gov data demonstrates that this research, which was first posted on August 1st 2016, is still recruiting participants. An estimated 30 individuals need to be signed up from a single medical centre."

Answered by AI

Is this clinical trial currently seeking participants?

"Affirmative. Evidenced on clinicaltrials.gov, this study is actively searching for participants to join the trial which was launched August 1st, 2016 and modified November 30th 2021. The research team is targeting 30 people from a single location."

Answered by AI

Is the eligibility criteria of this research project allowing individuals over 35 to participate?

"This experiment is searching for individuals aged between 14 and 30 years."

Answered by AI

What adverse effects have been observed in patients taking aminolevulinic acid?

"Supported by Phase 2 trial data, our team at Power assigned aminolevulinic acid a safety rating of 2; though there is evidence that it may be safe to use, efficacy has yet to be observed."

Answered by AI

Have there been any other investigations related to the efficacy of aminolevulinic acid?

"At present, 18 investigations into aminolevulinic acid are in progress. 2 of these trials have progressed to Phase 3. Most research sites for this drug reside in Lebanon, New hampshire; however, there are 56 locations conducting clinical trials around the world."

Answered by AI

May I be eligible to participate in this experiment?

"This clinical trial is inviting 30 patients with neurofibroma aged between 14 and 30 to take part. The American Academy of Neurology Guidelines must confirm the diagnosis, while the tumour should be cutaneous, trunk-based or in a limb no deeper than 4mm beneath the skin. Importantly, consent from participants must be given for them to comply with follow up requirements; moreover, any other malignancies disqualify potential candidates from inclusion."

Answered by AI

Who else is applying?

What site did they apply to?
The Medical College of Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Provider recommended. Increasing number and size of neurofibromas.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II
Donald Basel 2016. "Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02728388.
All > Photodynamic Therapy > Neurofibromatosis
~5 spots leftby Dec 2025
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