Kybella vs Asclera for Neurofibroma

Recruiting in Palo Alto (17 mi)

Overseen ByRichard R Anderson, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will evaluate the tolerability and effectiveness of two treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: Kybella and Asclera injection. Each patient will have a treatment and a control site.

Eligibility Criteria

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.

Inclusion Criteria

I am seeking treatment for cutaneous neurofibromatosis.

I have been diagnosed with NF1 through genetic testing or clinical evaluation.

I have at least 6 noticeable skin growths on my trunk, arms, or legs.

Exclusion Criteria

I am unable to understand or follow the study's requirements.

I have difficulty swallowing.

I have a recent blood clot.

I have bleeding issues or am on blood thinning medication.

Participant Groups

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.

2Treatment groups

Active Control

Group I: Asclera InjectionActive Control1 Intervention

Group II: Kybella InjectionActive Control1 Intervention