Neurofibromatosis 1 (NF1)NCT06934928
Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1-associated Cutaneous Neurofibromas (cNFs)
A study testing GentleMax Pro (with skin cooling) and GentleMax Pro (without skin cooling) in people with Neurofibromatosis 1 (NF1) and Neurofibromatosis Type I, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurofibromatosis 1 (NF1), Neurofibromatosis Type I
- What is being tested?
- GentleMax Pro (with skin cooling) and GentleMax Pro (without skin cooling)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1 Associated Cutaneous Neurofibromas (cNFs)
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.
Read more
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.
- Being tested
- GentleMax Pro (with skin cooling), GentleMax Pro (without skin cooling)
- Keywords
- Neurofibromatosis, NF1, Cutaneous Neurofibroma, cNF, GentleMax Pro
- Medical subject headings
- Neurofibromatosis 1, Neurofibromatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleMax Pro (with skin cooling)Device
Also called Alexandrite Laser, 755 nm Laser, Dynamic Cryogen Spray Cooling Device, DCD
Treatment will be performed with the GentleMax Pro laser (755 nm wavelength), which targets hemoglobin.
A negative pressure hand piece provides temporary, mild suction (~1/2 atm) before laser exposure.
A pulse fluence of 60-100 J/cm2 (single or double pulse) will be used with 8 mm diameter exposure spot size, and 3 ms pulse duration.
The laser system includes a dynamic cryogen spray cooling device (DCD) for epidermal protection. A spurt of cryogen cools the epidermis just before arrival of the treatment laser pulse.
GentleMax Pro (without skin cooling)Device
Also called Alexandrite Laser, 755 nm Laser
Treatment will be performed with the GentleMax Pro laser (755 nm wavelength), which targets hemoglobin.
A negative pressure hand piece provides temporary, mild suction (~1/2 atm) before laser exposure.
A pulse fluence of 60-100 J/cm2 (single or double pulse) will be used with 8 mm diameter exposure spot size, and 3 ms pulse duration.
| Study group | Role | What they receive |
|---|---|---|
| Treated cutaneous neurofibromas (cNFs) | Active comparator | Participants will receive treatment with laser at a wavelength of 755 nm to the cutaneous Neurofibromas lesion. Receives: Device: GentleMax Pro (with skin cooling); Device: GentleMax Pro (without skin cooling) |
| Control cutaneous neurofibromas (cNFs) | No intervention | A complementary region of cNFs of similar characteristics to the treatment area in the same body region will be selected to serve as an untreated control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Treatment will be considered tolerable if <40% of participants treated have a >Grade 2 CTCAE v5 adverse event (AE).
Measured: Anytime from initiation of treatment through study completion, an average of 8 months.
Secondary outcomes (7)
Patient Global Assessment of cNF Improvement (Likert Scale)
Patient rates degree of change of treated cNFs on a scale from -3 (very much worse) to 3 (very large improvement).
Measured: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
Clinician Global Assessment of cNF Improvement (Likert Scale)
Clinician rates degree of change of treated cNFs on a scale from -3 (very much worse) to 3 (very large improvement).
Measured: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
VAS Pain Scale
Participants will be asked to rate their pain using a visual analog scale (0 to 10) at each treatment visit and 1 week after each treatment.
Measured: Baseline, every 30 days (up to Day 240).
Patient Satisfaction
Satisfaction with each treatment modality is rated from 1 (very unsatisfied) to 5 (very satisfied).
Measured: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
Rate of Healing
Measured clinically via photography completed by a member of the study team at baseline, and all in-person visits.
Measured: Baseline, every 30 days (up to Day 240).
cNF Appearance (Height)
Clinically completed 3D Cherry Imaging. Change from baseline in height of cNFs.
Measured: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
cNF Appearance (Volume)
Clinically completed 3D Cherry Imaging. Change from baseline in volume of cNFs.
Measured: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Study is currently not funded at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis 1 (NF1)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- Richard R. Anderson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934928
- Sponsor's protocol ID
- 2025P000283
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Repeat, Monthly Treatments of Alexandrite Laser for NF1 Associated Cutaneous Neurofibromas (cNFs)
- ClinicalTrials.gov ID
- NCT06934928
- Acronym / sponsor ID
- 2025P000283
- Keywords
- Neurofibromatosis, NF1, Cutaneous Neurofibroma, cNF, GentleMax Pro
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is currently not funded at this time.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated cutaneous neurofibromas (cNFs) | Active comparator | Device: GentleMax Pro (with skin cooling), Device: GentleMax Pro (without skin cooling)Participants will receive treatment with laser at a wavelength of 755 nm to the cutaneous Neurofibromas lesion. |
| Control cutaneous neurofibromas (cNFs) | No intervention | –A complementary region of cNFs of similar characteristics to the treatment area in the same body region will be selected to serve as an untreated control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GentleMax Pro (with skin cooling)Also: Alexandrite Laser, 755 nm Laser, Dynamic Cryogen Spray Cooling Device, DCDTreatment will be performed with the GentleMax Pro laser (755 nm wavelength), which targets hemoglobin. A negative pressure hand piece provides temporary, mild suction (~1/2 atm) before laser exposure. A pulse fluence of 60-100 J/cm2 (single or double pulse) will be used with 8 mm diameter exposure spot size, and 3 ms pulse duration. The laser system includes a dynamic cryogen spray cooling device (DCD) for epidermal protection. A spurt of cryogen cools the epidermis just before arrival of the treatment laser pulse. | Device | Treated cutaneous neurofibromas (cNFs) |
| GentleMax Pro (without skin cooling)Also: Alexandrite Laser, 755 nm LaserTreatment will be performed with the GentleMax Pro laser (755 nm wavelength), which targets hemoglobin. A negative pressure hand piece provides temporary, mild suction (~1/2 atm) before laser exposure. A pulse fluence of 60-100 J/cm2 (single or double pulse) will be used with 8 mm diameter exposure spot size, and 3 ms pulse duration. | Device | Treated cutaneous neurofibromas (cNFs) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Anytime from initiation of treatment through study completion, an average of 8 months.
Treatment will be considered tolerable if <40% of participants treated have a >Grade 2 CTCAE v5 adverse event (AE).
7 secondary outcomes
Patient Global Assessment of cNF Improvement (Likert Scale)
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
Clinician Global Assessment of cNF Improvement (Likert Scale)
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
VAS Pain Scale
Time frame: Baseline, every 30 days (up to Day 240).
Patient Satisfaction
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
Rate of Healing
Time frame: Baseline, every 30 days (up to Day 240).
cNF Appearance (Height)
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
cNF Appearance (Volume)
Time frame: Baseline, Day 90, and 30 days after final treatment (up to Day 240).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard R. Anderson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GentleMax Pro (with skin cooling) and GentleMax Pro (without skin cooling) in people with Neurofibromatosis 1 (NF1) and Neurofibromatosis Type I, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: Anytime from initiation of treatment through study completion, an average of 8 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.