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Transcutaneous Auricular Vagus Nerve Stimulation for Rosacea

This study is testing a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) for rosacea, specifically for people with moderate to severe redness and flushing. taVNS involves using a device to stimulate a nerve in the ear. Researchers want to see if this treatment can reduce your rosacea symptoms and improve your quality of life. They will measure changes in your redness (Clinician's Erythema Assessment) and how rosacea affects your daily life (Dermatology Quality Life Index) after 4 weeks of treatment. You can join if you are an adult aged 18 or older with a dermatologist-confirmed diagnosis of rosacea and at least moderate disease. The study is currently unclear on its recruitment status.

Study design
This is a small, single-arm pilot study, meaning all 10 participants will receive the taVNS treatment. It is not specified if the study is blinded.
What's involved
You would receive taVNS treatment for 4 weeks. Your total participation in the study is expected to last 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an additional 4 weeks after the 4-week treatment period to see how long the results last.

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NCT07600424

Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea

Recruiting
NAAges 18+InterventionalTreatment
Brigham and Women's Hospital
~10 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Transaricular vagus nerve stimulation (taVNS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)
Measured over Week 4
+1 more outcome measured

Conditions

Rosacea
Rosacea, Erythematotelangiectatic
Flushing

Explore related trials

RosaceaRosacea, erythematous telangiectatic type

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Liset Chacin
[email protected]
617-264-5926
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)Week 4

    The CEA is a static 5-point grading scale of facial erythema severity. The scale is 0 to 4. A positive result, means that the erythema, redness was reduced. A negative result indicates that the erythema increased.

  • Change from baseline to week 4 in the Dermatology Quality Life Index (DLQI)Week 4

    The DLQI is a dermatology-specific quality of life instrument to measure the impact of skin disease on different aspects of health-related quality of life. The questionnaire contains 10 questions, each scored on a 4-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.