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Kybella vs Asclera for Neurofibroma

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
Seeking treatment for cNF
Diagnosis of NF1 based on germline genetic testing or meeting specific clinical criteria
Must not have
Unable to give informed consent or adhere to study schedule
Dysphagia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months after treatment, 6 months after treatment, 12 months after treatment
Awards & highlights

Summary

This trial will look at if Kybella & Asclera injections are effective & safe for treating Neurofibromatosis Type 1 Cutaneous Neurofibromas. Patients will have one site treated & one as a control.

Who is the study for?
Adults over 18 with Neurofibromatosis Type 1 and at least six paired cutaneous neurofibromas on their trunk, arms, or legs can join this trial. Participants must not be pregnant, have a history of severe allergies to the study substances, bleeding disorders, or be undergoing other treatments for their skin lesions.
What is being tested?
The trial is testing Kybella and Asclera injections on different sites of the body to see which one is better tolerated and more effective in treating Neurofibromatosis Type 1 related skin tumors.
What are the potential side effects?
Possible side effects include pain at the injection site, swelling, bruising, numbness, redness and hardness in the treatment area. There may also be risks of nerve injury leading to facial muscle weakness or an uneven smile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am seeking treatment for cutaneous neurofibromatosis.
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I have been diagnosed with NF1 through genetic testing or clinical evaluation.
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I have at least 6 noticeable skin growths on my trunk, arms, or legs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or follow the study's requirements.
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I have difficulty swallowing.
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I have a recent blood clot.
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I have bleeding issues or am on blood thinning medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months after treatment, 6 months after treatment, 12 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months after treatment, 6 months after treatment, 12 months after 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 (ClinRO)
Modified SkinDex for cNF
Treatment specific patient reported outcomes (PRO)
Other study objectives
Biologic effect
Rate of healing
cNF appearance

Trial Design

2Treatment groups
Active Control
Group I: Kybella InjectionActive Control1 Intervention
Group II: Asclera InjectionActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,307 Previous Clinical Trials
14,861,889 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,701 Total Patients Enrolled
2 Trials studying Neurofibromatosis
151 Patients Enrolled for Neurofibromatosis
Richard R Anderson, MDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
81 Total Patients Enrolled
~7 spots leftby Sep 2025
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