Malar Bags After Lower Lid Blepharoplasty and Facelift: A Randomized Controlled Trial of the Effects of Tacrolimus
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Malar edema
研究概览
简要总结
Elective lower eyelid surgery is a common cosmetic procedure. Facial swelling is a common complication. Studies suggest that this facial swelling is part of a complex inflammatory process. Topical tacrolimus has long been used to treat various inflammatory skin disorders. By combining our knowledge of facial swelling and tacrolimus mechanism of action, we can hypothesize that it can be used as a treatment to prevent this post-operative swelling. The purpose of this project is to apply topical tacrolimus to one of the patient's cheeks following facial surgery and compare the incidence of facial swelling to the opposite side control cheek.
详细描述
1.0 Purpose:
To perform a randomized controlled trial to determine if topical tacrolimus ointment reduces incidence or severity of post-operative facial edema and malar bags after elective blepharoplasty and/or facelift.
2.0 Hypothesis:
Topical tacrolimus will reduce the incidence and severity of post-operative facial edema presenting as malar bags after blepharoplasty and/or facelift.
3.0 Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients will receive a container for each cheek where the contents will be randomized between the study ointment and the control ointment. Only one investigator will have knowledge of the contents. The care providor, patient, and assessor will all be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral lower lid blepharoplasty, facelift, or both.
- •Patients over 18 years of age.
排除标准
- •-Patients presenting for revision surgery.
- •Patients with a known allergy to tacrolimus.
- •Patients taking medications that alter tacrolimus metabolism:
- •Anticonvulsants: carbamazepine, phenobarbital, phenytoin
- •Antibiotics: rifampicin, rifabutin
- •Antifungal: clotrimazole, ketoconazole, fluconazole, itraconazole
- •Ca++ channel blockers: diltiazem, nifedipine, nicardipine, verapamil
- •Macrolides: erythromycin, clarithromycin, troleandomycin
- •Miscellaneous: cyclosporin A, danazol, bromocriptine, cimetidine, methylprednisolone, protease inhibitors
- •Patients with previously diagnosed reduced kidney function.
- •Immunocompromised patients.
- •Patients with a history of cutaneous facial malignancies.
- •Patients with active cutaneous facial infections.
研究组 & 干预措施
Tacrolimus Treatment
Tacrolimus Topical 0.1% Topical Ointment
干预措施: Tacrolimus Topical 0.1% Topical Ointment (Drug)
Control
Patients will be self matched controls with one cheek receiving the study ointment and the other receiving a control ointment (polysporin ointment).
干预措施: Polysporin Ointment (Drug)
结局指标
主要结局
Malar edema
时间窗: 6 months
Development of malar edema post operatively
次要结局
未报告次要终点
研究者
Richard Warren
Principal Investigator
University of British Columbia