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Not yet recruiting NCT07600424

Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea

No phase Interventional Rosacea Rosacea, Erythematotelangiectatic Flushing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transaricular vagus nerve stimulation (taVNS).
Who it may be relevant to
Registry conditions: Rosacea, Rosacea, Erythematotelangiectatic, Flushing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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)

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Change in the Dermatology Quality Life Index (DLQI) from baseline to week 4 & 8 [Time frame: Week 4, Week 8]
  • 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]
  • Change of Clinician's Erythema Assessment (CEA) scale from baseline to week 4 & 8 [Time frame: Week 4, Week 8]
  • Change from in Patient Health Questionnaire-9 (PHQ-9) scale from baseline to week 4 & 8 [Time frame: Week 4, Week 8]
  • Change in Generalized Anxiety Disorder-7 (GAD-7) scale from baseline to week 4 & 8 [Time frame: Week 4, Week 8]
  • DermSat-7 score at week 4 & week 8 [Time frame: Week 4, Week 8]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT07600424 · 2026P000835

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗