NCT07600424招募中不适用
Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea: A Pilot Trial
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
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
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Experimental
干预措施: Transaricular vagus nerve stimulation (taVNS) (Device)
研究者
John Barbieri
Clinician Investigator, Associate Professor of Dermatology
Brigham and Women's Hospital
研究点 (1)
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