RosaceaNCT07600424
Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea
A study testing Transaricular vagus nerve stimulation (taVNS) in people with Rosacea and Rosacea, Erythematotelangiectatic, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea, Rosacea, Erythematotelangiectatic, Flushing
- What is being tested?
- Transaricular vagus nerve stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02461
John Barbieri, MD, MBA, 617-264-5926, jbarbieri@bwh.harvard.edu
About this study
Official title: 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
- Conditions
- Rosacea, Rosacea, Erythematotelangiectatic, Flushing
- Being tested
- Transaricular vagus nerve stimulation (taVNS)
- Medical subject headings
- Rosacea, Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Rosacea | Experimental | Not described Receives: Device: Transaricular vagus nerve stimulation (taVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 4
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start23 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Barbieri, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600424
- Sponsor's protocol ID
- 2026P000835
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea: A Pilot Trial
- ClinicalTrials.gov ID
- NCT07600424
- Acronym / sponsor ID
- 2026P000835
- Conditions
- Rosacea, Rosacea, Erythematotelangiectatic, Flushing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 23 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosacea | Experimental | Device: Transaricular vagus nerve stimulation (taVNS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Rosacea |
Primary outcome
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transaricular vagus nerve stimulation (taVNS) in people with Rosacea and Rosacea, Erythematotelangiectatic, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liset Chacin (617-264-5926, lchacin@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 4 of Clinician's Erythema Assessment (CEA) (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.