Sign in
CompletedPhase 1

Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Status
Completed
Phase
Phase 1
People taking part
34 people enrolled
Started
2 Jun 2021
Ended
19 Apr 2024
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Kybella
  • 1064nm laser
  • 755nm Alexandrite Laser
Record updated
21 February 2025

Who can take part

Age
18 years to 85 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Adult males and females ≥18 years of age
  • Have a diagnosis of Neurofibromatosis Type 1
  • Patients must be seeking treatment for cutaneous Neurofibromas
  • Patients must have ≥ 6 paired cutaneous Neurofibromas (3 to be treated and 3 untreated) that are visible and measure between 2-4mm in size
  • Able and willing to comply with all visit, treatment and evaluation schedules and requirements
  • Able to understand and provide written informed consent
  • Access to a Smart Phone to be able to take and upload photographs to an application

Who cannot take part

  • Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
  • Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug
  • Known allergy to injectable anesthetics or deoxycholic acid
  • 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
  • Individuals who cannot give informed consent or adhere to study schedule
  • Actively tanning during the course of the study
  • Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists

Where in United States

  • Wellman Center for Photomedicine, Massachusetts General HospitalBoston, United States

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Kybella InjectionExisting treatment, for comparison

    Treatment: Kybella

  • 1064nm laserExisting treatment, for comparison
  • 755nm laserExisting treatment, for comparison

    Treatment: 755nm Alexandrite Laser

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
21 February 2025