Clinical trial · Interventional
Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas
NCT04730583CI-TRIAL-00086297completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Neurofibroma | Skin Neurofibroma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1064nm laser | Device | — | UNRESOLVED |
| 755nm Alexandrite Laser | Device | — | UNRESOLVED |
| Kybella | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Kybella Injection
- interventionNames
- Drug: Kybella
- type
- ACTIVE_COMPARATOR
- label
- 1064nm laser
- interventionNames
- Device: 1064nm laser
- type
- ACTIVE_COMPARATOR
- label
- 755nm laser
- interventionNames
- Device: 755nm Alexandrite Laser
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.