Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea

Mass General Brigham

Status: Enrolling

Conditions: Rosacea; Flushing; Rosacea, Erythematotelangiectatic

Treatments: Device: Transaricular vagus nerve stimulation (taVNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07600424

2026P000835

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Rosacea

Experimental group

Treatment:

Device: Transaricular vagus nerve stimulation (taVNS)