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

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

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..

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult ≥18 years of age
  2. Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 thefollowing criteria:
  3. Family history of NF1
  4. Six or more light brown ("cafe-au-lait") spots on the skin
  5. Presence of two or more neurofibromas of any type, or one or more plexiformneurofibromas
  6. Freckling under the arms or in the groin area
  7. Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
  8. A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bonebehind the eye, or dysplasia of long bones, often in the lower leg
  9. Tumor on the optic nerve that may interfere with vision
  10. Patients must be seeking treatment for cNF
  11. 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.
  12. cNF must be located on the trunk, arms or legs of the patient
  13. Able and willing to comply with all visit, treatment and evaluation schedules andrequirements
  14. Able to understand and provide written informed consent

Exclusion

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 oranesthetic creams) required for use in the study, if no alternative to the said agentexists;
  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 withantiplatelet or anticoagulant therapy.
  8. Those with dysphagia.
  9. 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 States

    Active - Recruiting

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