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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

Study 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.Check my eligibility

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.See study design

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.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, and 12 months, post-treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary outcome measures

Clinician Reported Outcomes

Patient Report Outcomes

Other outcome measures

Rate of healing

cNF Appearance

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,611 Total Patients Enrolled

2 Trials studying Neurofibromatosis

151 Patients Enrolled for Neurofibromatosis

Johns Hopkins UniversityOTHER

2,266 Previous Clinical Trials

14,837,467 Total Patients Enrolled

Richard R Anderson, MDPrincipal InvestigatorMassachusetts General Hospital

4 Previous Clinical Trials

71 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment accept participants who are fifty or older?

"The candidate selection for this research is restricted to those aged 18 and above but under 80 years old."

Answered by AI

Has the FDA sanctioned Kybella Injection?

"Kybella Injection's limited data on efficacy and safety makes it a relatively low risk, earning the drug a score of 1."

Answered by AI

Is it possible for me to register as a participant in this clinical trial?

"In order to be eligble for this clinical trial, individuals must possess neurofibromatosis and fall between the age range of 18-80. Approximately 30 patients are expected to join."

Answered by AI

Are there any unfilled positions for participants in this experiment?

"According to information on clinicaltrials.gov, the recruitment period for this medical trial has already concluded. This study was posted in December 1st of 2023 and last updated November 13th of same year; however, there are 55 other trials that require patient participation currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Richard Rox Anderson, MD 2024. "Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132165.

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