Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas (NCT04730583) | Clinical Trial Compass
CompletedPhase 1
Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas
United States34 participantsStarted 2021-06-02
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]