NCT06615453招募中不适用
A Prospective Study Assessing the Impact of Tixel Treatment of Peri Orbital Wrinkles on Symptoms and Signs in Patients With Dry Eye Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess the safety of periorbital Tixel treatments in patients with dry eye through the reporting of adverse events (AE) and serious adverse events (SAE) exclusively.
研究概览
简要总结
This study will examine how a standard Tixel treatment versus a sham treatment for eye wrinkles affects the symptoms and signs of Dry Eye Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Mild to Moderate Periorbital wrinkles
- •OSDI score of at least 23
- •Noninvasive Tear film break up time (NIBUT) ≤ 10 seconds
- •No other eye or skin or immune problems
- •Willing and able to provide written informed consent.
- •Willing to participate in all study activities and instructions.
排除标准
- •Pregnancy and/or breastfeeding
- •Lesions in the periorbital area
- •Acute severe blepharitis
- •Acute conjunctivitis
- •Use of eye drops within 2 hours before examination
- •Other concomitant anterior eye disease
- •Has undergone outdoors/sunbed tanning during the last 4 weeks
- •Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
- •Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
- •Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
- •An impaired immune system condition or use of immunosuppressive medication.
- •Collagen disorders, keloid formation and/or abnormal wound healing.
- •Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred.
- •Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.
- •Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
- •Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
- •Any patient who has tattoos or permanent makeup in the treated area.
- •Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
- •Any patient who underwent thread lifting of the area to be treated in the last 3 months.
研究组 & 干预措施
Tixel treatment
Experimental
干预措施: Thermo-mechanical action based peri-orbital fractional skin treatment (Device)
Sham treatment
Sham Comparator
干预措施: Sham treatment (Device)
结局指标
主要结局
To assess the safety of periorbital Tixel treatments in patients with dry eye through the reporting of adverse events (AE) and serious adverse events (SAE) exclusively.
时间窗: Through study completion, an average of 4 months
SAFETY, number of AEs Any safety related event during the study will be recorded and analyzed
次要结局
- To evaluate the impact of the treatment on symptoms and signs of dry eyes and compare the findings with those of a control group.(Through study completion, an average of 4 months)
研究者
研究点 (1)
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