Status:
COMPLETED
Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Cutaneous Neurofibroma
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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, a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
- 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;
- 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;
- Pregnant females, due to possible discomfort with the procedure even though the procedure is localized and there is no new drug.
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04730583
Start Date
June 2 2021
End Date
April 19 2024
Last Update
February 21 2025
Active Locations (1)
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1
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114