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Ear stimulation device could tame rosacea flushing

NCT ID NCT07600424

Symptom relief Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This pilot study will test whether a device that gently stimulates a nerve in the ear (taVNS) can reduce facial redness and flushing in people with rosacea. Ten adults with moderate-to-severe rosacea will use the device daily for 4 weeks, then be followed for another 4 weeks to see if any benefits last. The study measures changes in redness and quality of life.

What this could mean

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

Active substance
transcutaneous auricular vagus nerve stimulation (taVNS) device
What this could lead to
If it works, this could point toward a drug-free way to reduce facial redness and flushing in rosacea.
What could go wrong
This is a very small pilot study with only 10 people and no placebo group, so results may not be reliable or apply to everyone. The device is still experimental.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

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 years and older

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: * Adults aged 18 years of age and older * Dermatologist confirmed diagnosis of rosacea * Clinician's Erythema Assessment of at least 3 (moderate to severe disease) * Willingness to adhere to current rosacea regimen without additions or laser treatments (e.g. PDL) during the study period. Exclusion Criteria: * Changes to rosacea regimen (prescription topical or oral medications) within 4 weeks of randomization. * Facial hair, tattoos, or other characteristics that would interfere with erythema assessments * History of symptomatic cardiac arrythmias (e.g. heart block, sick sinus syndrome, bradyarrhythmia) * Presence of a pacemaker, implanted defibrillator, or neurostimulator * Seizure disorder or epilepsy * Trigeminal Neuralgia within the past year * Severe coronary disease or recent myocardial infarction within the past 5 years * Severe autonomic dysfunction (e.g., frequent syncope, hospitalization) * History of recurrent syncope or unexplained fainting * Use of brimonidine or oxymetazoline within the past 4 weeks * Use of beta-blockers, anticholinergics, or vagal-modulating drugs within the past 4 weeks * Severe phymatous rosacea * Ear deformity, piercings, or other condition that prevents the use of the taVNS device * Known hypersensitivity to electrode materials * Patients who are pregnant.

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Conditions

The condition(s) this trial relates to.

Flushing rosacea

As listed by the trial registrant

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

Flushing Rosacea Rosacea, erythematotelangiectatic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02461, United States

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