Using skin cooling to reduce pain from treatments for neurofibromatosis type 1 skin tumors

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

This study tests if cooling the skin can help make treatments for skin tumors from neurofibromatosis type 1 feel less painful for patients.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06132165 on ClinicalTrials.gov

What this trial studies

This study evaluates how effective skin cooling is in making four different treatments for Neurofibromatosis Type 1 Cutaneous Neurofibromas more tolerable. The treatments include two types of lasers, radio-frequency injection, and Kybella injection. Each participant will have both a treatment site and a control site to compare the effects. The goal is to improve patient comfort during these non-invasive procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Neurofibromatosis Type 1 and visible cutaneous neurofibromas suitable for treatment.

Not a fit: Patients who do not have Neurofibromatosis Type 1 or those with fewer than six visible cutaneous neurofibromas may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the comfort and tolerability of treatments for patients with neurofibromatosis type 1.

How similar studies have performed: While this specific approach is novel, similar studies exploring pain reduction techniques in dermatological treatments have shown promising results.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts

• Wellman Center for Photomedicine — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Richard R Anderson, MD — Massachusetts General Hospital
• Study coordinator: Devon Gunter

Conditions Neurofibromatosis 1