Recruiting

taVNS

Sponsor:

Brigham and Women's Hospital

Code:

NCT07600424

Conditions

Rosacea

Rosacea, Erythematotelangiectatic

Flushing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transaricular vagus nerve stimulation (taVNS)

Study Details

Brief 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

Conditions

Rosacea

Rosacea, Erythematotelangiectatic

Flushing

Study ID

NCT07600424

Start date

May 23, 2026

Status verified date

May, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rosacea

Interventions

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)

Primary outcome measure

  • Change from baseline to week 4 of Clinician's Erythema Assessment (CEA) [ Time Frame: Week 4 ]
  • Change from baseline to week 4 in the Dermatology Quality Life Index (DLQI) [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Liset Chacin

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

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02461

Contacts

John Barbieri, MD, MBA

617-264-5926jbarbieri@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-08-14.