Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Pharmaceutical Solutions

Gastrointestinal Agents

Chrysarobin

Polidocanol

Deoxycholic Acid

Sclerosing Solutions

Kybella is sterile 1% deoxycholic acid provided in a 2 mL single-use vial.

Asclera is sterile 1% polidocanol provided in a 2 mL single-use vial.

The laser used is the GentleMax Pro laser (755/1064 nm wavelength) which targets hemoglobin.

Injection into the cutaneous Neurofibromas lesion.

Kybella

Asclera

Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion.

755nm Alexandrite Laser

Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion

1064nm Nd:YAG Laser

Devon Gunter

Richard R Anderson, MD

This study will evaluate the tolerability and effectiveness of four FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and Kybella and Polidocanol injections. Each patient will have a treatment and a control site.

This study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. If there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. Three treatment visits with the crossover treatment will then take place.

Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs)

Measured clinically via photography completed by a member of the study team at baseline, 1 month, 2 month, 5 month and if applicable, 6 month, 7 month and 10 month post-treatment.

Clinically completed 2D and 3D photography Cherry Imaging. Change from baseline in volume of cNFs.

Clinically completed 2D and 3D photography Cherry Imaging. Change from baseline in height of cNFs.

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.

Patient rates degree of pain experienced prior to, during, and after treatments on a scale of 0-10. Satisfaction with each treatment modality is rated from 0 (very unsatisfied) to 5 (very satisfied).

Validated measure assessing of the effects of skin diseases on patients' quality of life on a scale of 0 (never bothered) to 5 (always bothered).

Using questionnaires we will determine the patients' reported outcomes. Patient Global Assessment: Patient rates degree of change of treated and control cNFs on a scale from 1 (no change) to 7 (very large improvement).

Using questionnaires we will determine the clinicians' reported outcomes. Physician Global Assessment: Clinician rates degree of change of treated and control cNFs on a scale from 1 (no change) to 7 (very large improvement).

Johns Hopkins University

Massachusetts General Hospital

Principal Investigator

Pain

Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion.

1064nm Nd:YAG laser

Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion

Gina-Fae Fillingham

Fernanda Sakamoto, MD, PhD

Patricia Richey, MD

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..

Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Measured by photography completed by member at medical team

Measured via clinically completed 2D and 3D photography

Using questionnaires, we will determine the patients' reported outcomes.

Using questionnaires we will determine the clinicians' reported outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs)	NCT06300502	Neurofibromas, ... Neurofibromatos...	Kybella Asclera 755nm Alexandri... 1064nm Nd:YAG L...	18 Years - 85 Years	Massachusetts General Hospital
Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas	NCT06132165	Neurofibromatos...	Deoxycholic Aci... Polidocanol 1064nm Nd:YAG l... 755nm Alexandri...	18 Years - 80 Years	Massachusetts General Hospital

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