Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1-associated Cuta… (NCT06934928) | Clinical Trial Compass
SuspendedNot Applicable
Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1-associated Cutaneous Neurofibromas (cNFs)
Stopped: Study is currently not funded at this time.
United States10 participantsStarted 2027-01
Plain-language 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 Neurofibromas (cNFs). The main questions it aims to answer are:
Will performing up to 6 months of treatment sessions with alexandrite laser will result in tolerable local skin reactions and reduction in both individual cNF size by \>50% as well as improved cNF appearance in the treated field? If there is a comparison group: Researchers will compare laser treatment with cooling to both laser treatment without cooling and an untreated control see if laser treatments are effective and if cooling makes treatment more tolerable.
Participants will:
* Receive up to 6 monthly laser treatments.
* Complete surveys asking about pain during and after treatments.
* Complete surveys asking about satisfaction with the treatments.
* Undergo 2D photography and 3D imaging of treatment areas.
* Optionally, receive biopsies of up to 6 treated lesions to investigate characteristics of tumors that respond well to treatment as well as non-respondent tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Participant cannot give informed consent or adhere to study schedule.
* Participant is Fitzpatrick skin type V-VI.
* Participant is actively…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial for using Alexandrite laser on NF1-related skin neurofibromas is currently listed as suspended — do you know why it's suspended, and whether that changes whether I should consider it at all?
2Since this study is in an unspecified phase and its primary goal is measuring safety and tolerability rather than proving the treatment works, what does that tell us about how much is actually known about whether this laser approach is effective for cutaneous neurofibromas?
3Are there any already-established or standard treatments for NF1-associated cutaneous neurofibromas that might make more sense for me to try before waiting to see if this suspended trial reopens?
4If this trial does resume, what kinds of treatment-emergent adverse events would you be watching for with monthly Alexandrite laser sessions on neurofibromas, and how serious could those risks be for someone with my specific situation?
5Given that this would involve repeat monthly laser treatments, what would the realistic time commitment and follow-up schedule look like, and how would that fit around my other NF1-related care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Timeframe: Anytime from initiation of treatment through study completion, an average of 8 months.