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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06132165
Other study ID # 2023P002152
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 1, 2024
Est. completion date October 31, 2024

Study information

Verified date February 2024
Source Massachusetts General Hospital
Contact Devon Gunter
Phone 617-724-2168
Email wellmancrc@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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..


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Adult =18 years of age 2. Have a diagnosis of NF1 based on germline genetic testing or by meeting = 2 the following criteria: 1. Family history of NF1 2. Six or more light brown ("cafe-au-lait") spots on the skin 3. Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas 4. Freckling under the arms or in the groin area 5. Two or more pigmented, benign bumps on the eye's iris (Lisch nodules) 6. A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg 7. Tumor on the optic nerve that may interfere with vision 3. Patients must be seeking treatment for cNF 4. Patients must have = 6 paired cNF (3 to be treated and 3 untreated) that are visible and measure between 2-8mm in size. These must be in areas amenable to treatment and surveillance with digital photography. 5. cNF must be located on the trunk, arms or legs of the patient 6. Able and willing to comply with all visit, treatment and evaluation schedules and requirements 7. Able to understand and provide written informed consent Exclusion Criteria: 1. Individuals who cannot give informed consent or adhere to study schedule. 2. Actively tanning during the course of the study. 3. 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; 4. Known allergy to injectable anesthetics, deoxycholic acid or polidocanol. 5. Women who are pregnant. 6. Those with acute thromboembolic diseases. 7. Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy. 8. Those with dysphagia. 9. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Deoxycholic Acid
Injection into the cutaneous Neurofibromas lesion.
Polidocanol
Injection into the cutaneous Neurofibromas lesion.
Device:
1064nm Nd:YAG laser
Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion.
755nm Alexandrite Laser
Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion

Locations

Country Name City State
United States Wellman Center for Photomedicine Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Rate of healing Measured by photography completed by member at medical team Baseline, 3 months, 6 months, and 12 months, post-treatment
Other cNF Appearance Measured via clinically completed 2D and 3D photography Baseline, 3 months, 6 months, and 12 months, post-treatment
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 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. 3 months after treatment
Secondary Patient Report Outcomes Using questionnaires, we will determine the patients' reported outcomes. For the 12 months after treatment
Secondary Clinician Reported Outcomes Using questionnaires we will determine the clinicians' reported outcomes. For the 12 months after treatment
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