Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study will evaluate the effectiveness of skin cooling in increasing tolerability of four treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 980nm laser, a 755nm laser, radio-frequency injection, and a Kybella injection. Each patient will have a treatment and a control site..

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Adult ≥18 years of age

• Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:

‣ Family history of NF1

⁃ Six or more light brown (cafe-au-lait) spots on the skin

⁃ Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas

⁃ Freckling under the arms or in the groin area

⁃ Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)

⁃ A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg

⁃ Tumor on the optic nerve that may interfere with vision

• Patients must be seeking treatment for cNF

• Patients must have ≥ 6 paired cNF (3 to be treated and 3 untreated) that are visible and measure between 2-8mm in size. These must be in areas amenable to treatment and surveillance with digital photography.

• cNF must be located on the trunk, arms or legs of the patient

• Able and willing to comply with all visit, treatment and evaluation schedules and requirements

• Able to understand and provide written informed consent

Locations
United States
Massachusetts
Wellman Center for Photomedicine
RECRUITING
Boston
Contact Information
Primary
Devon Gunter
wellmancrc@partners.org
617-724-2168
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2024-10-31
Participants
Target number of participants: 30
Treatments
Active_comparator: Kybella Injection
Active_comparator: Asclera Injection
Active_comparator: 1064nm laser
Active_comparator: 755nm laser
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Johns Hopkins University

This content was sourced from clinicaltrials.gov