Last updated: February 7, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Warts
Brain Tumor
Treatment
Polidocanol
Deoxycholic Acid
1064nm Nd:YAG laser
Clinical Study ID
NCT06132165
2023P002152
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult ≥18 years of age
- Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 thefollowing 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 plexiformneurofibromas
- 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 bonebehind the eye, or dysplasia of long bones, often in the lower leg
- Tumor on the optic nerve that may interfere with vision
- Patients must be seeking treatment for cNF
- Patients must have ≥ 6 paired cNF (3 to be treated and 3 untreated) that are visibleand measure between 2-8mm in size. These must be in areas amenable to treatment andsurveillance with digital photography.
- cNF must be located on the trunk, arms or legs of the patient
- Able and willing to comply with all visit, treatment and evaluation schedules andrequirements
- Able to understand and provide written informed consent
Exclusion
Exclusion Criteria:
- 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 oranesthetic creams) required for use in the study, if no alternative to the said agentexists;
- Known allergy to injectable anesthetics, deoxycholic acid or polidocanol.
- Women who are pregnant.
- Those with acute thromboembolic diseases.
- Those with bleeding abnormalities or those who are currently being treated withantiplatelet or anticoagulant therapy.
- Those with dysphagia.
- Any condition which, in the Investigator's opinion, would make it unsafe (for theparticipant or study personnel) to treat the participant as part of this researchstudy.
Study Design
Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Polidocanol
Phase: 1
Study Start date:
March 01, 2024
Estimated Completion Date:
October 31, 2024
Connect with a study center
Wellman Center for Photomedicine
Boston, Massachusetts 02114
United StatesActive - Recruiting
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