Transcutaneous Auricular Vagus Nerve Stimulation for Rosacea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm pilot trial in adults with rosacea and at least moderate facial redness. Participants will receive transcutaneous auricular vagus nerve stimulation for 4 weeks, followed by 4 weeks of observation to see if benefits persist. The study will monitor changes in redness and flushing as evaluated by clinicians while participants maintain their usual rosacea treatment. Key safety checks will exclude people with certain heart, seizure, or implanted device conditions. The goal is to determine feasibility, tolerability, and preliminary effectiveness of taVNS for rosacea symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Liset Chacin
• Email: lchacin@bwh.harvard.edu
• Phone: 617-264-5926

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.