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

Eligibility 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
• 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.