NCT05007288已完成不适用
A Single Center Evaluation of Restorative Eye Treatment and Inhance With Trihex Technology Effects on the Aesthetic Outcomes When Used Pre and Post Upper Blepharoplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Collagen Content
研究概览
简要总结
The purpose of this research is to determine if restorative eye treatment (RET) and Inhance with trihex technology used before and after blepharoplasty can lead to better skin quality before undergoing blepharoplasty, and if these products will lead to less visible scarring and faster healing after blepharoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Men and women who are about to have blepharoplasty at the Bascom Palmer Eye Institute by Dr. Wendy Lee.
- •Men and women with no known medical conditions that, in the investigator's opinion, may affect wound healing and interfere with study participation (e.g. diabetes, skin disorder etc.).
- •Participants willing to provide consent for photographic release.
- •Participants must not be using any new skincare products, other than the study products provided, on the treatment area for the duration of the study.
- •Participants willing to avoid extended periods of sun exposure and all use of tanning beds for the duration of the study.
- •Participants must be willing to refrain from any other treatments or procedures to the treatment area during the duration of the study.
- •18 years old or older.
排除标准
- •Any dermatological disorder or poor health, which in the investigator's opinion, may interfere with the accurate evaluation of the participants' skin characteristics or inhibit wound healing.
- •Participants who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- •Participants that have been using topical products around their upper or lower eyes within 30 days.
- •Participants who are, in the opinion of the investigator, unwilling or unable to comply with the requirements of the protocol.
- •Pregnant or lactating participants will be excluded, as well as participants planning on becoming pregnant during the study duration.
- •Participants with recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing).
- •A participant with a history of keloids or hypertrophic scars.
- •Participants known to harbour a blood borne disease (e.g. Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV ), HIV)
- •Special populations: Prisoners, Pregnant women, Adults unable to consent, Individuals who are not yet adults.
- •Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
结局指标
主要结局
Collagen Content
时间窗: Up to 1 month prior to blepharoplasty surgery
Assessed from eyelid tissue samples
Elastin Content
时间窗: Up to 1 month prior to blepharoplasty surgery
Assessed from eyelid tissue samples
Post operative bruising
时间窗: Up to 2 weeks post blepharoplasty surgery
Bruising will be assessed on a 1-5 scale with the higher score indicating more bruising.
次要结局
- Post operative swelling(Up to 2 weeks post blepharoplasty surgery)
研究者
Wendy Lee
Professor of Ophthalmology
University of Miami
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Selective Retina Therapy With 'R:GEN' in Patients With Central Serous ChorioretinopathyCentral Serous ChorioretinopathyNCT03758963LUTRONIC Corporation63
已完成
3 期
A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic GlaucomaNon-infectious Anterior UveitisUveitic GlaucomaNCT05042609Tarsier Pharma142
已完成
不适用
Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 ModelsCataractNCT03856944Gainesville Eye Associates29
已完成
4 期
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye SyndromeKeratoconjunctivitis SiccaNCT02139033Ocusoft, Inc.42
已完成
不适用
Dexamethasone Intravitreal Implant in Retinal Vein OcclusionMacular Edema, CystoidNCT03559491Università degli Studi dell'Insubria30