Effectiveness of Hirudoid on Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A - A Real-World Multicenter, Prospective, Interventional Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Area (extent) of ecchymosis around the eye
研究概览
简要总结
Botulinum toxin type A (commonly referred to as 'Botox') injections are a treatment that dermatologists regularly use to smoothen wrinkles such as 'Crow's feet', to rejuvenate the skin surrounding the eye (the 'periorbital region'). However, botulinum toxin type A can be associated with injection-site bruising that may take up to 2 weeks to heal.
Hirudoid, an ointment that is applied to the skin, has been shown to reduce the severity of swelling and bruising after facial cosmetic procedures. The objective of this study is to study the effectiveness of Hirudoid in reducing the severity of bruising following the use of botulinum toxin type A for periorbital rejuvenation of Crow's feet in adult patients.
The knowledge gained from this study can help to develop an effective medicated skincare regimen that helps to minimize the complications of botulinum toxin type A and speed up recovery time, which may be of benefit to patients who receive botulinum toxin type A injections for treatment of Crow's feet.
详细描述
This is an investigator-initiated, real-world, multicenter, prospective, interventional study to assess the effectiveness of topical Hirudoid for both preventing, and reducing the severity (intensity and extent) of ecchymosis after periorbital rejuvenation with botulinum toxin type A. This will be an intra-individual comparison study, where the study drug will be applied to one side of the face, and the other half of the face will receive no treatment.
Planned follow up is up to 10 days with assessments scheduled at Days 1, 2, 5, 7, and 10 post-botulinum toxin type A injection. The total number of mandatory in-person visits would be 2, including a visit on the day of botulinum toxin type A injection (Day 0), and a follow-up visit on Day 7 post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adults (age ≥18 years) undergoing periorbital rejuvenation procedures with botulinum toxin type A (e.g., improvement in the appearance of moderate-to-severe lateral canthal lines)
- •Patients willing to participate in the study and return for the scheduled follow-up visit, be photographed as a part of the study procedures, and sign the informed consent form
排除标准
- •Known allergy to Hirudoid or any components of Hirudoid
- •Known allergy to Botulinum toxin type A
- •Previous cosmetic surgery or visible scars in the treatment area
- •Severe atrophy or weakness in the target muscles
- •Use of local anesthetic prior to Botulinum toxin type A administration
- •Current or recent use of anticoagulant or corticosteroid therapy
- •Current cigarette smoker
- •History of clotting or coagulation disorders
- •History of cardiovascular, metabolic, endocrine, liver or renal diseases or any underlying medical condition that may interfere with the study procedures or assessments
- •Patients suffering from any psychiatric condition
- •Patients taking any agent (e.g., aminoglycoside antibiotics) or suffering from any disorder (e.g., myasthenia gravis, Eaton-Lambert syndrome) that may interfere with neuromuscular function
- •Pregnant or lactating women
- •Patients unwilling to be photographed or sign the informed consent form
研究组 & 干预措施
Hirudoid
All enrolled and eligible participants who are planning to receive botulinum toxin type A for lateral canthal lines will receive the study drug (Hirudoid).
干预措施: Hirudoid (heparinoids) ointment, 3mg/g (Drug)
结局指标
主要结局
Area (extent) of ecchymosis around the eye
时间窗: Day 7 post-procedure with botulinum toxin type A
Area (extent) of ecchymosis around the eye with Hirudoid versus 'no treatment' on day 7 post-procedure with botulinum toxin type A for the treatment of lateral canthal lines. Patients will be instructed to take daily photographs of both sides of face, which will be shared with clinician and analysed with online software to measure area of bruising using a freehand selection tool to trace the border. Results are to be inputted into the electronic case record form in cm2. A separate independent assessment will take place for each image, by a second physician who is blinded to initial results.
次要结局
- Intensity of ecchymosis around the eye(Days 1, 2, 5, 7 and 10 post-procedure with botulinum toxin type A)
- Duration (days until resolution) of ecchymosis(Day 1 to Day 10 post-procedure with botulinum toxin type A)
- Global patient satisfaction(Day 7 post-procedure with botulinum toxin type A)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Day 1 to Day 10 post-procedure with botulinum toxin type A)
- Area (extent) of ecchymosis around the eye(Days 1, 2, 5 and 10 post-procedure with botulinum toxin type A)