Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea

Purpose

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

Conditions

  • Rosacea
  • Rosacea, Erythematotelangiectatic
  • Flushing

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rosacea
  • Device: Transaricular vagus nerve stimulation (taVNS)
    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)

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02461
Contact:
John Barbieri, MD, MBA
617-264-5926
jbarbieri@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Liset Chacin
617-264-5926
lchacin@bwh.harvard.edu