Actively Recruiting

Phase 2
Age: 14Years - 30Years
All Genders
NCT02728388

Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

Led by Donald Basel · Updated on 2025-05-08

30

Participants Needed

1

Research Sites

487 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The investigators wish to determine the time to disease progression for benign neurofibromas treated with Levulan Kerastick topical photosensitizer and red light photodynamic therapy (PDT) in patients with neurofibromatosis type 1 (NF1). The investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

CONDITIONS

Official Title

Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

Who Can Participate

Age: 14Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 14 years or older.
  • Diagnosed NF1, determined by American Academy of Neurology Guidelines.
  • Tumor location on skin of trunk or limbs only.
  • Tumor type: superficial dermal neurofibromas 4mm deep or less.
  • Patient has provided written informed consent.
  • Patient is willing and able to comply with study follow-up requirements.
  • Absence of any other malignancy.
Not Eligible

You will not qualify if you...

  • Life expectancy less than 3 years.
  • Pregnancy.
  • Cutaneous photosensitivity to wavelengths used in photodynamic therapy.
  • Diagnosis of porphyria.
  • Allergy to aminolevulinic acid or any topical solution vehicle components.
  • Previous chemotherapy within 6 weeks before photodynamic therapy.
  • Receiving other concurrent tumor therapy.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Donald G Basel

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

D

Donald G Basel, MD

CONTACT

P

Paula Engelking, BS, CRC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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