Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)
研究概览
简要总结
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
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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.
排除标准
- 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.
研究组 & 干预措施
Rosacea
干预措施: Transaricular vagus nerve stimulation (taVNS) (Device)
结局指标
主要结局
Change from baseline to week 4 of Clinician's Erythema Assessment (CEA)
时间窗: 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)
时间窗: 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.
次要结局
- Change in the Dermatology Quality Life Index (DLQI) from baseline to week 4 & 8(Week 4, Week 8)
- Change from week 4 to week 8 in Global Flushing Severity Score (GFSS) from baseline to week 4 & 8(Week 4, Week 8)
- Change of Clinician's Erythema Assessment (CEA) scale from baseline to week 4 & 8(Week 4, Week 8)
- Change from in Patient Health Questionnaire-9 (PHQ-9) scale from baseline to week 4 & 8(Week 4, Week 8)
- Change in Generalized Anxiety Disorder-7 (GAD-7) scale from baseline to week 4 & 8(Week 4, Week 8)
- DermSat-7 score at week 4 & week 8(Week 4, Week 8)
研究者
John Barbieri
Clinician Investigator, Associate Professor of Dermatology
Brigham and Women's Hospital
研究点 (1)
标识符
- NCT 编号
- NCT07600424
- 其他研究编号
- 2026P000835
日期
- 首次提交
- (4个月前)
- 首次发布
- (4个月前)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (5个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否