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NCT04730583 · ClinicalTrials.gov registry record · Phase 1

Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas

A Phase 1 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT04730583: Completed Phase 1 study, sponsored by Massachusetts General Hospital.

NCT04730583 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04730583, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

This study will evaluate the tolerability and effectiveness of three FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and a Kybella injection. Each patient will have a treatment and a control site.

Primary Outcome

Device based treatment will be considered tolerable if \<40% of participants treated have a \>grade 2 adverse event (AE). A grade 2 AE is defined as an event that requires treatment.

Interventions

  • DEVICE 755nm Alexandrite Laser
  • DRUG Kybella
  • DEVICE 1064nm laser

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2021-06-02
Est. Completion 2024-04-19
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT04730583 record still lists

NCT04730583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 3 interventions - of which 755nm Alexandrite Laser is the first listed.

NCT04730583 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04730583 about?

NCT04730583 is a clinical study titled "Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas". This study will evaluate the tolerability and effectiveness of three FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and a Kybella injection. Each patient will have a treatment and a control site.

What is the current status of trial NCT04730583?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2021-06-02. Estimated completion is 2024-04-19.

What interventions are being tested in trial NCT04730583?

The interventions under investigation include: 755nm Alexandrite Laser (DEVICE), Kybella (DRUG), 1064nm laser (DEVICE).

Who is sponsoring clinical trial NCT04730583?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04730583's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04730583, the US trial registry maintained by the National Library of Medicine. NCT04730583 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.