What this study is
A single arm, pilot study among individuals with rosacea and at least moderate flushing or rednesss will be enrolled in a 4-week trial of taVNS. The particicpants will be followed for an additional 4-weeks following the intervention period to evaluate the durability of the results
What's being tested
- Transaricular vagus nerve stimulation (taVNS)
Intervention · DEVICE
This project consists of a 4-week trial of transaricular vagus nerve stimulation (taVNS) for rosacea. Participation is expected to last for a total duration of 8 weeks (4 week active intervention period)
Study details
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea: A Pilot Trial
- Sponsor
- Brigham and Women's Hospital
- Conditions
- Rosacea · Rosacea, Erythematotelangiectatic · Flushing
- Enrolling
- 10 people
- Starts
- 2026-05-23
- Est. completion
- 2028-02-28
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBrigham and Women's Hospital
Boston, Massachusetts, United States
- John Barbieri, MD, MBA · Contact617-264-5926jbarbieri@bwh.harvard.edu
Recruiting
Study team
Sponsor
Brigham and Women's Hospital
Study ID 2026P000835
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.