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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months after treatment, 6 months after treatment, 12 months after treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months after treatment, 6 months after treatment, 12 months after treatment

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

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 (ClinRO)

Modified SkinDex for cNF

Treatment specific patient reported outcomes (PRO)

Other outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER

2,266 Previous Clinical Trials

14,837,477 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,621 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

Frequently Asked Questions

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

Can new participants join this experiment at present?

"Affirmative. As attested to by clinicaltrials.gov, this medical study is currently recruiting patients and was initially posted on December 6th 2022 with the most recent update seen on November 1st 2023. The trial necessitates a total of 20 participants from one location."

Answered by AI

What are the potential risks associated with Kybella Injection?

"Kybella Injection has only received limited clinical support, so it was given a safety rating of 1."

Answered by AI

Is there an age cutoff for participation in this research experiment?

"This study accepts participants between the ages of 18 and 85, in line with its eligibility requirements."

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What demographics are authorized to participate in this trial?

"To join this trial, patients must have a medical diagnosis of neurofibromatosis and be between 18-85 years old. In total, the study is looking for 20 participants to partake in their research."

Answered by AI

How many participants are partaking in this clinical investigation?

"Affirmative. The information on clinicaltrials.gov demonstrates that this trial is presently recruiting participants. This medical study was initially advertised on December 6th 2022 and has most recently been updated on November 1st 2023, with the intention of enrolling a total of 20 patients from one site."

Answered by AI