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Device

Skin Cooling for Cutaneous Neurofibroma Pain Management

Phase 1
Recruiting
Led By Richard R Anderson, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of NF1 based on germline genetic testing or by meeting specific criteria including family history of NF1, presence of characteristic skin spots, neurofibromas, freckling, Lisch nodules, bony lesions, and optic nerve tumor
Seeking treatment for cNF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, and 12 months, post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine how cooling the skin helps to make treatments for Neurofibromatosis Type 1 Cutaneous Neurofibromas more tolerable. Treatments include lasers & injections. Each patient will have a treatment & control site.

Who is the study for?
This trial is for adults over 18 with Neurofibromatosis Type 1 who want to treat visible neurofibromas on their trunk, arms, or legs. Participants need at least six paired cutaneous neurofibromas (3 treated, 3 untreated) between 2-8mm in size and must be able to follow the study's schedule.
What is being tested?
The study tests if skin cooling can make four treatments more bearable for patients with Neurofibromatosis Type 1: a laser treatment using either a 980nm or a 755nm laser, radio-frequency injection, and Kybella injection. Each patient will have both treated and untreated spots compared.
What are the potential side effects?
Potential side effects from the treatments may include discomfort at the site of treatment, redness, swelling, bruising from injections or lasers used during procedures. Skin cooling aims to reduce these pain-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with NF1 through genetic testing or by having specific symptoms.
Select...
I am seeking treatment for cutaneous neurofibromatosis.
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I have at least 6 visible skin growths between 2-8mm on my trunk, arms, or legs.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, and 12 months, post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, and 12 months, post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Clinician Reported Outcomes
Patient Report Outcomes
Other study objectives
Rate of healing
cNF Appearance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: Kybella InjectionActive Control1 Intervention
Group II: Asclera InjectionActive Control1 Intervention
Group III: 755nm laserActive Control1 Intervention
Group IV: 1064nm laserActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,012 Previous Clinical Trials
13,309,236 Total Patients Enrolled
2 Trials studying Neurofibromatosis
151 Patients Enrolled for Neurofibromatosis
Johns Hopkins UniversityOTHER
2,325 Previous Clinical Trials
14,874,850 Total Patients Enrolled
Richard R Anderson, MDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
71 Total Patients Enrolled
~18 spots leftby Nov 2025
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