Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea
2026年8月12日 更新者：John Barbieri、Brigham and Women's Hospital
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
研究概览
研究类型
介入性
注册 (估计的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Liset Chacin
- 电话号码：617-264-5926
- 邮箱：lchacin@bwh.harvard.edu
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02461
- 招聘中
- Brigham and Women's Hospital
-
接触：
- John Barbieri, MD, MBA
- 电话号码：617-264-5926
- 邮箱：jbarbieri@bwh.harvard.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Rosacea
|
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)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)
大体时间：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.
|
Week 4
|
|
Change from baseline to week 4 in the Dermatology Quality Life Index (DLQI)
大体时间：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.
|
Week 4
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the Dermatology Quality Life Index (DLQI) from baseline to week 4 & 8
大体时间：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.
|
Week 4, Week 8
|
|
Change from week 4 to week 8 in Global Flushing Severity Score (GFSS) from baseline to week 4 & 8
大体时间：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).
|
Week 4, Week 8
|
|
Change from in Patient Health Questionnaire-9 (PHQ-9) scale from baseline to week 4 & 8
大体时间：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
|
Week 4, Week 8
|
|
Change in Generalized Anxiety Disorder-7 (GAD-7) scale from baseline to week 4 & 8
大体时间：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).
|
Week 4, Week 8
|
|
Change of Clinician's Erythema Assessment (CEA) scale from baseline to week 4 & 8
大体时间：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.
|
Week 4, Week 8
|
|
DermSat-7 score at week 4 & week 8
大体时间：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.
|
Week 4, Week 8
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月23日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年2月28日
研究注册日期
首次提交
2026年5月15日
首先提交符合 QC 标准的
2026年5月15日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.