Dosing and Tolerability of Deoxycholic Acid vs. Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Inclusion criteria

• Adult males and females ≥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 per modality (3 treated and 3 untreated). cNF should be 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

Exclusion criteria

• Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
• Individuals who cannot give informed consent or adhere to study schedule
• Actively tanning during the course of the study
• 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;
• Known allergy to injectable anesthetics, polidocanol or deoxycholic acid
• Those with acute thromboembolic diseases
• Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy
• Those with dysphagia
• Women who are pregnant
• 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