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Fat-Dissolving drug may shrink NF1 skin tumors

NCT ID NCT06300502

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether monthly injections of Kybella (a drug that dissolves fat) can safely shrink skin tumors in people with Neurofibromatosis Type 1. Up to 15 adults will receive up to 6 monthly treatments, and researchers will compare treated and untreated tumors to see if the drug reduces size and improves appearance. The goal is to find a tolerable, non-surgical option for these growths.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant is an adult ≥18 years of age. 2. Participant has a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria: * Family history of NF1, * Six or more light brown ("cafe-au-lait") spots on the skin, * Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas, * Freckling under the arms or in the groin area, * Two or more pigmented, benign bumps on the eye's iris (Lisch nodules), * A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg, * Tumor on the optic nerve that may interfere with vision. 3. Participant is seeking treatment for cNF. 4. Participant has ≥ 6 paired cNF that are visible and measure 2 mm or more in size. The target treatment area must be amenable to both deoxycholate injections and surveillance with digital and 3D photography. Preferred locations are trunk (back or chest), arms and legs. 5. Participant is able and willing to comply with all visit, treatment and evaluation schedules and requirements. 6. Participant is able to understand and provide written informed consent. 7. Participant has no known allergy to deoxycholate. 8. Participant has no concurrent injury or wound in the target area. Exclusion Criteria: 1. Participant cannot give informed consent or adhere to study schedule. 2. Participant is actively tanning during the course of the study. 3. Participant has a known allergy to deoxycholic acid. 4. For female participants: those who are pregnant. 5. Participant has any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study.

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Conditions

The condition(s) this trial relates to.

neurofibroma neurofibromatosis type 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurofibromas, cutaneous Neurofibromatosis 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Wellman Center for Photomedicine

    Boston, Massachusetts, 02114, United States

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