Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Donald Basel
Study ID
NCT02728388
Phase
PHASE2
Status
Recruiting
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Conditions

  • NEUROFIBROMATOSIS 1

Eligibility Criteria

Sex
ALL
Age
14 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • aminolevulinic acid — DRUG
    Drug: Levulan Kerastick Drug: Topical placebo Device: Omnilux Revive Procedure: Photodynamic therapy Other: Tumor growth rate measurements

Study Details

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.

Key Dates

Start date
Aug 31, 2016
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PDT Treatment
    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).

Primary Outcome Measure

Time to disease progression [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Donald G BaselMilwaukeeWisconsin53226
Donald G Basel, MD
[email protected]
4142664921
Paula Engelking
[email protected]
4142663289

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