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Trial Title:
Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs)
NCT ID:
NCT06300502
Condition:
Neurofibromas, Cutaneous
Neurofibromatosis 1
Conditions: Official terms:
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Deoxycholic Acid
Polidocanol
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Kybella
Description:
Injection into the cutaneous Neurofibromas lesion.
Arm group label:
Kybella Injection
Other name:
Deoxycholate
Intervention type:
Drug
Intervention name:
Asclera
Description:
Injection into the cutaneous Neurofibromas lesion.
Arm group label:
Asclera Injection
Other name:
Polidocanol
Intervention type:
Device
Intervention name:
755nm Alexandrite Laser
Description:
Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion.
Arm group label:
755nm laser
Intervention type:
Device
Intervention name:
1064nm Nd:YAG Laser
Description:
Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion
Arm group label:
1064nm laser
Summary:
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.
Criteria for eligibility:
Criteria:
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:
- Family history of NF1
- Six or more light brown ("cafe-au-lait") spots on the skin
- Presence of two or more neurofibromas of any type, or one or more plexiform
neurofibromas
- Freckling under the arms or in the groin area
- Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
- A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone
behind the eye, or dysplasia of long bones, often in the lower leg
- 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. Known allergy to deoxycholic acid or polidocanol.
4. Women who are pregnant.
5. Those with acute thromboembolic diseases.
6. Those with bleeding abnormalities or those who are currently being treated with
antiplatelet or anticoagulant therapy.
7. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wellman Center for Photomedicine
Address:
City:
Boston
Zip:
02114
Country:
United States
Start date:
June 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
Johns Hopkins University
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300502