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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Rosacea |
|
Recruiting Locations
Brigham and Women's Hospital
Boston, Massachusetts 02461
Boston, Massachusetts 02461
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital