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Chill out: skin cooling may ease pain of NF1 treatments

NCT ID NCT06132165

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether cooling the skin before or during laser and injection treatments for neurofibromatosis type 1 (NF1) skin bumps can reduce pain. Thirteen adults with NF1 received four different treatments (two lasers and two injections) on both cooled and non-cooled skin areas. The main goal was to see if cooling made the procedures more tolerable and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Skin cooling (ice or cold device) applied before or during laser or injection treatments
What this could lead to
If it works, skin cooling could make existing treatments for NF1 skin bumps less painful and more tolerable.
What could go wrong
This is a very small Phase 1 study with only 13 people, so results may not apply to everyone. The cooling might not reduce pain enough to matter.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult ≥18 years of age 2. Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria: 1. Family history of NF1 2. Six or more light brown ("cafe-au-lait") spots on the skin 3. Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas 4. Freckling under the arms or in the groin area 5. Two or more pigmented, benign bumps on the eye's iris (Lisch nodules) 6. A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg 7. Tumor on the optic nerve that may interfere with vision 3. Patients must be seeking treatment for cNF 4. Patients must have ≥ 6 paired cNF (3 to be treated and 3 untreated) that are visible and measure between 2-8mm in size. These must be in areas amenable to treatment and surveillance with digital photography. 5. cNF must be located on the trunk, arms or legs of the patient 6. Able and willing to comply with all visit, treatment and evaluation schedules and requirements 7. Able to understand and provide written informed consent Exclusion Criteria: 1. Individuals who cannot give informed consent or adhere to study schedule. 2. Actively tanning during the course of the study. 3. Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists; 4. Known allergy to injectable anesthetics, deoxycholic acid or polidocanol. 5. Women who are pregnant. 6. Those with acute thromboembolic diseases. 7. Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy. 8. Those with dysphagia. 9. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Wellman Center for Photomedicine

    Boston, Massachusetts, 02114, United States

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