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Laser Therapy

755nm laser for Neurofibromatosis

Phase 1

Waitlist Available

Led By Richard R Anderson, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 2 month, 5 month and if applicable, 6 month, 7 month and 10 month.

Awards & highlights

Study Summary

"This trial will test four FDA-approved treatments for Neurofibromatosis Type 1 Cutaneous Neurofibromas: a 1064nm laser, a 755nm laser, and Kyb

Who is the study for?

This trial is for individuals with Neurofibromatosis Type 1 who have skin tumors known as Cutaneous Neurofibromas. Participants should be willing to undergo multiple treatment sessions and allow for a control site on their body to remain untreated for comparison.Check my eligibility

What is being tested?

The study tests the effectiveness of four FDA-approved treatments: two types of lasers (1064nm Nd:YAG and 755nm Alexandrite) and injections (Kybella and Asclera). Patients will receive repeated monthly treatments, with an option to switch if there's no improvement after three visits.See study design

What are the potential side effects?

Potential side effects may include skin irritation, redness, swelling at the injection or laser sites, pain during treatment, possible scarring or changes in skin pigmentation. The severity can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 2 month, 5 month and if applicable, 6 month, 7 month and 10 month.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 2 month, 5 month and if applicable, 6 month, 7 month and 10 month.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 2 month, 5 month and if applicable, 6 month, 7 month and 10 month. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary outcome measures

Clinician Reported Outcomes

Numeric Rating Scale (NRS-11)/Patient Satisfaction

Patient Reported Outcomes

+1 more

Other outcome measures

Rate of healing

cNF appearance (height)

cNF appearance (volume)

Trial Design

4Treatment groups

Active Control

Group I: 755nm laserActive Control1 Intervention

The laser used is the GentleMax Pro laser (755/1064 nm wavelength) which targets hemoglobin.

Group II: 1064nm laserActive Control1 Intervention

The laser used is the GentleMax Pro laser (755/1064 nm wavelength) which targets hemoglobin.

Group III: Kybella InjectionActive Control1 Intervention

Kybella is sterile 1% deoxycholic acid provided in a 2 mL single-use vial.

Group IV: Asclera InjectionActive Control1 Intervention

Asclera is sterile 1% polidocanol provided in a 2 mL single-use vial.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,929 Previous Clinical Trials

13,198,295 Total Patients Enrolled

2 Trials studying Neurofibromatosis

151 Patients Enrolled for Neurofibromatosis

Johns Hopkins UniversityOTHER

2,260 Previous Clinical Trials

14,820,770 Total Patients Enrolled

Richard R Anderson, MDPrincipal InvestigatorMassachusetts General Hospital

4 Previous Clinical Trials

91 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the scope of this research include individuals who have surpassed 75 years of age?

"Individuals aged 18 to 85 years old are eligible for enrollment in this trial according to the specified age criteria."

Answered by AI

Are there any available openings for patients to participate in this study?

"As per the data on clinicaltrials.gov, patient recruitment for this study is presently not underway. The trial was initially listed on June 1st, 2024 and last updated on March 7th, 2024. Although this particular trial is not actively seeking participants currently, there are fifty alternative trials that are open for enrollment at present."

Answered by AI

What are the criteria for individuals who meet the requirements to participate in this trial?

"Individuals aged between 18 and 85 with a diagnosis of neurofibromatosis are sought for participation in this trial, which has availability for approximately 10 eligible candidates."

Answered by AI

What is the level of safety associated with the 1064nm laser treatment for individuals?

"According to our team at Power, the safety rating for the 1064nm laser is assigned a level of 1 on a scale from 1 to 3. This evaluation corresponds with it being a Phase 1 trial where there exists minimal data validating both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs)

Richard Rox Anderson, MD 2024. "Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06300502.

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