NCT07600424NARecruiting
Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea
Brigham and Women's Hospital
Start Date
5/23/2026
Completion Date
2/28/2028
Summary
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
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
Transaricular vagus nerve stimulation (taVNS)
Conditions
RosaceaRosacea, ErythematotelangiectaticFlushing
Locations
Brigham and Women's Hospital
Boston, Massachusetts 02461
United States