Status:
NOT_YET_RECRUITING
Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1-associated Cutaneous Neurofibromas (cNFs)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Neurofibromatosis 1 (NF1)
Neurofibromatosis Type I
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to evaluate the tolerability and effectiveness of multiple treatments of Alexandrite (755 nm) Laser in those with Neurofibromatosis Type 1 (NF1) Cutaneous Neurofibro...
Eligibility Criteria
Inclusion
- Participant is an adult ≥18 years of age.
- Participant has a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:
- Family history of NF1
- Six or more light brown ("cafe-au-lait") spots on the skin
- Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas
- Freckling under the arms or in the groin area
- Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
- A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg
- Tumor on the optic nerve that may interfere with vision
- Participant is seeking treatment for cNF.
- Participants must have ≥ 12 paired cNF (6 to be treated without DCD, 6 to be treated with DCD) that are visible and measure at least 2 mm in size in the target treatment area. The target treatment area must be amenable to both laser treatments and surveillance with digital and 3D photography. Preferred locations are trunk (back or chest), arms and legs.
- Participant is able and willing to comply with all visit, treatment, and evaluation schedules and requirements.
- Participant is able to understand and provide written informed consent.
- Participant has no concurrent injury or wound in the target area.
Exclusion
- Participant cannot give informed consent or adhere to study schedule.
- Participant is Fitzpatrick skin type V-VI.
- Participant is actively tanning during the course of the study.
- For female participants: participant is pregnant.
- Participant has 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06934928
Start Date
June 1 2025
End Date
April 1 2026
Last Update
April 18 2025
Active Locations (1)
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1
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114