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

NCT ID: NCT06132165

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-07-31

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..

Conditions

Neurofibromatosis 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Kybella Injection

Group Type: ACTIVE_COMPARATOR

Deoxycholic Acid

Intervention Type: DRUG

Injection into the cutaneous Neurofibromas lesion.

Asclera Injection

Group Type: ACTIVE_COMPARATOR

Polidocanol

Intervention Type: DRUG

Injection into the cutaneous Neurofibromas lesion.

1064nm laser

Group Type: ACTIVE_COMPARATOR

1064nm Nd:YAG laser

Intervention Type: DEVICE

Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion.

755nm laser

Group Type: ACTIVE_COMPARATOR

755nm Alexandrite Laser

Intervention Type: DEVICE

Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion

Interventions

Deoxycholic Acid

Injection into the cutaneous Neurofibromas lesion.

Intervention Type: DRUG

Polidocanol

Injection into the cutaneous Neurofibromas lesion.

Intervention Type: DRUG

1064nm Nd:YAG laser

Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion.

Intervention Type: DEVICE

755nm Alexandrite Laser

Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion

Intervention Type: DEVICE

Other Intervention Names

Kybella; Asclera

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Richard Rox Anderson, MD

Director, Wellman Center for Photomedicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard R Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Wellman Center for Photomedicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2023P002152

Identifier Type: -

Identifier Source: org_study_id