ClinicalTrials.gg
RecruitingNCT07600424Updated Aug 14, 2026

Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea

An interventional study of Transaricular vagus nerve stimulation (taVNS) in Rosacea, Rosacea, Erythematotelangiectatic and Flushing, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Rosacea
  • Rosacea, Erythematotelangiectatic
  • Flushing

Browse trials for

03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's planned enrollment of 10 is below the median of 61 across 200 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to electrode materials
  • Patients who are pregnant.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Rosacea

    Device: Transaricular vagus nerve stimulation (taVNS)

Interventions

  • DeviceTransaricular 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)

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 4

  2. 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.

    Time frame: Week 4

Secondary outcomes

  1. 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.

    Time frame: Week 4, Week 8

  2. 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).

    Time frame: Week 4, Week 8

  3. 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.

    Time frame: Week 4, Week 8

  4. 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

    Time frame: Week 4, Week 8

  5. 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).

    Time frame: Week 4, Week 8

  6. 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.

    Time frame: Week 4, Week 8

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07600424
Responsible party
John Barbieri (Clinician Investigator, Associate Professor of Dermatology, Brigham and Women's Hospital) — Principal investigator
First posted
May 20, 2026
Start date
May 23, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Aug 14, 2026

Study contacts

Liset Chacin
Contact
lchacin@bwh.harvard.edu
617-264-5926

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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