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Laser Therapy

Multiple Treatments for Skin Tumors

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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Clinician Reported Outcomes
Numeric Rating Scale (NRS-11)/Patient Satisfaction
Patient Reported Outcomes
+1 more
Other study objectives
Rate of healing
cNF appearance (height)
cNF appearance (volume)

Trial Design

4Treatment groups
Active Control
Group I: Asclera InjectionActive Control1 Intervention
Asclera is sterile 1% polidocanol provided in a 2 mL single-use vial.
Group II: 755nm 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: 1064nm laserActive Control1 Intervention
The laser used is the GentleMax Pro laser (755/1064 nm wavelength) which targets hemoglobin.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,711 Total Patients Enrolled
2 Trials studying Neurofibromatosis
151 Patients Enrolled for Neurofibromatosis
Johns Hopkins UniversityOTHER
2,307 Previous Clinical Trials
14,861,899 Total Patients Enrolled
Richard R Anderson, MDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
91 Total Patients Enrolled
~7 spots leftby Dec 2025
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