Print

Purpose

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..

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Adult ≥18 years of age 2. Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria: 1. Family history of NF1 2. Six or more light brown ("cafe-au-lait") spots on the skin 3. Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas 4. Freckling under the arms or in the groin area 5. Two or more pigmented, benign bumps on the eye's iris (Lisch nodules) 6. A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg 7. Tumor on the optic nerve that may interfere with vision 3. Patients must be seeking treatment for cNF 4. 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. 5. cNF must be located on the trunk, arms or legs of the patient 6. Able and willing to comply with all visit, treatment and evaluation schedules and requirements 7. Able to understand and provide written informed consent

Exclusion Criteria

  1. Individuals who cannot give informed consent or adhere to study schedule. 2. Actively tanning during the course of the study. 3. Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists; 4. Known allergy to injectable anesthetics, deoxycholic acid or polidocanol. 5. Women who are pregnant. 6. Those with acute thromboembolic diseases. 7. Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy. 8. Those with dysphagia. 9. Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Kybella Injection
  • Drug: Deoxycholic Acid
    Injection into the cutaneous Neurofibromas lesion.
    Other names:
    • Kybella
Active Comparator
Asclera Injection
  • Drug: Polidocanol
    Injection into the cutaneous Neurofibromas lesion.
    Other names:
    • Asclera
Active Comparator
1064nm laser
  • Device: 1064nm Nd:YAG laser
    Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion.
Active Comparator
755nm laser
  • Device: 755nm Alexandrite Laser
    Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion

Recruiting Locations

Wellman Center for Photomedicine
Boston, Massachusetts 02114
Contact:
Gina-Fae Fillingham
617-726-3308
gfillingham@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Devon Gunter
617-724-2168
wellmancrc@partners.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.