Frontlight ResearchEarly access
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