Wellman Center for Photomedicine
Boston, Massachusetts, 02114, United States
NCT Number: NCT06132165
This study will evaluate the effectiveness of skin cooling in increasing tolerability of four treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 980nm laser, a 755nm laser, radio-frequency injection, and a Kybella injection. Each patient will have a treatment and a control site..
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Boston, Massachusetts, 02114, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection into the cutaneous Neurofibromas lesion.
Other names: Kybella
Injection into the cutaneous Neurofibromas lesion.
Other names: Asclera
Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion.
Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion
Time frame: 3 months after treatment
Device based treatment will be considered tolerable if <40% of participants treated have a >grade 2 adverse event (AE). A grade 2 AE is defined as an event that requires treatment.
Time frame: For the 12 months after treatment
Using questionnaires, we will determine the patients' reported outcomes.
Time frame: For the 12 months after treatment
Using questionnaires we will determine the clinicians' reported outcomes.
Time frame: Baseline, 3 months, 6 months, and 12 months, post-treatment
Measured by photography completed by member at medical team
Time frame: Baseline, 3 months, 6 months, and 12 months, post-treatment
Measured via clinically completed 2D and 3D photography
Massachusetts General Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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