Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06132165 | RECRUITING | Neurofibromatosis 1

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

Massachusetts General Hospital

Information provided by (Responsible Party):

Richard Rox Anderson, MD

Brief 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..

Condition or disease

Neurofibromatosis 1

Intervention/treatment

Deoxycholic Acid

Polidocanol

1064nm Nd:YAG laser

755nm Alexandrite Laser

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas
Actual Study Start Date : 2024-03-01
Estimated Primary Completion Date : 2024-10-31
Estimated Study Completion Date : 2024-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • 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.
Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Location Details

NCT06132165

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Wellman Center for Photomedicine

Boston, Massachusetts, United States, 02114