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

NCT07600424 | Not Yet Recruiting

• 1 other identifier: 2026P000835
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in the Dermatology Quality Life Index (DLQI) from baseline to week 4 & 8

  Week 4, Week 8

• Change from week 4 to week 8 in Global Flushing Severity Score (GFSS) from baseline to week 4 & 8

  Week 4, Week 8

• Change of Clinician's Erythema Assessment (CEA) scale from baseline to week 4 & 8

  Week 4, Week 8

• Change from in Patient Health Questionnaire-9 (PHQ-9) scale from baseline to week 4 & 8

  Week 4, Week 8

• Change in Generalized Anxiety Disorder-7 (GAD-7) scale from baseline to week 4 & 8

  Week 4, Week 8

Study Arms (1)

Rosacea

EXPERIMENTAL

Device: Transaricular vagus nerve stimulation (taVNS)

Interventions

Transaricular vagus nerve stimulation (taVNS) DEVICE

This project consists of an 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)

Rosacea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02461, United States

Location

MeSH Terms

Conditions

Rosacea; Flushing

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liset Chacin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator, Associate Professor of Dermatology

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)