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NCT Number: NCT07600424

Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea

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

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Key information

Conditions

Rosacea Flushing Pathological Conditions, Signs and Symptoms Rosacea, Erythematotelangiectatic Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02461, United States

Location contact

John Barbieri, MD, MBA

CONTACT

[email protected]

617-264-5926

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transaricular vagus nerve stimulation (taVNS)

Device

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 outcomes

  1. Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)

    Time frame: Week 4

    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.

  2. Change from baseline to week 4 in the Dermatology Quality Life Index (DLQI)

    Time frame: Week 4

    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.

Secondary outcomes

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

    Time frame: Week 4, Week 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.

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

    Time frame: Week 4, Week 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).

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

    Time frame: Week 4, Week 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.

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

    Time frame: Week 4, Week 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

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

    Time frame: Week 4, Week 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).

  6. DermSat-7 score at week 4 & week 8

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liset Chacin

CONTACT

[email protected]

617-264-5926

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 20, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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