Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea

Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea: A Pilot Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rosacea; Flushing; Rosacea, Erythematotelangiectatic
• Intervention / Treatment: Device: Transaricular vagus nerve stimulation (taVNS)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liset Chacin; Phone Number: 617-264-5926; Email: lchacin@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02461
      • Brigham and Women's Hospital
      • Contact: John Barbieri, MD, MBA; Phone Number: 617-264-5926; Email: jbarbieri@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)	The CEA is a static 5-point grading scale of facial erythema severity. The scale is 0 to 4. A positive result, means that the erythema, redness was reduced. A negative result indicates that the erythema increased.	Week 4
Change from baseline to week 4 in the Dermatology Quality Life Index (DLQI)	The DLQI is a dermatology-specific quality of life instrument to measure the impact of skin disease on different aspects of health-related quality of life. The questionnaire contains 10 questions, each scored on a 4-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Dermatology Quality Life Index (DLQI) from baseline to week 4 & 8	The DLQI is a dermatology-specific quality of life instrument to measure the impact of skin disease on different aspects of health-related quality of life. The questionnaire contains 10 questions, each scored on a 4-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.	Week 4, Week 8
Change from week 4 to week 8 in Global Flushing Severity Score (GFSS) from baseline to week 4 & 8	The GFSS is a 0-10 numeric rating scale assessing facial flushing symptoms including redness, warmth, tingling, or itching over the past 24 hours, with scores ranging from: 0 (did not have), 1-3 (mild), 4-6 (moderate), 7-9 (severe), 10 (extreme).	Week 4, Week 8
Change from in Patient Health Questionnaire-9 (PHQ-9) scale from baseline to week 4 & 8	The PHQ-9 is a widely used tool for assessing depression severity, with scores ranging from 0 to 27 based on the frequency of symptoms over the past two weeks	Week 4, Week 8
Change in Generalized Anxiety Disorder-7 (GAD-7) scale from baseline to week 4 & 8	The GAD-7 evaluates anxiety severity with scores ranging from 0 to 21, using a similar structure to the PHQ-9. Scores are categorized as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).	Week 4, Week 8
Change of Clinician's Erythema Assessment (CEA) scale from baseline to week 4 & 8	The CEA is a static 5-point grading scale of facial erythema severity. The scale is 0 to 4. A positive result, means that the erythema, redness, was reduced. A negative result indicates that the erythema increased.	Week 4, Week 8
DermSat-7 score at week 4 & week 8	The DermSat7 is a 7-item, self-administered questionnaire designed to assess patient satisfaction with dermatologic treatments. It covers three domains - effectiveness (3 items), convenience (3 items), and overall satisfaction (1 item) - with responses on a 5-point (or 5-point) satisfaction scale, then transformed into a 0-100 scale so that higher scores indicate greater satisfaction.	Week 4, Week 8

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Flushing; Rosacea
• Other Study ID Numbers: 2026P000835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No