The Effectiveness of Topical Silicone Application Combined With Photoprotection in the Development of Scarring Following Blepharoplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objetive evaluation
研究概览
简要总结
Assess the efficacy of utilizing topical silicone with photoprotection (Improscar Stick® 50) on the quality of healing following upper blepharoplasty, employing the Vancouver and POSAS scales (both patient and observer) over a minimum follow-up period of three months.
详细描述
This study is a clinical, experimental, prospective, and comparative before-and-after investigation involving participants undergoing upper blepharoplasty. Individuals aged between 18 and 70 years will be included in the study. Clinical assessments will be conducted at four distinct time points: one week postoperatively (coinciding with suture removal and the initiation of treatment), one week following the commencement of treatment, at one month, and three months post-treatment. The Vancouver and POSAS scales, both subjective and objective, will be employed for evaluation. For inferential analysis, ANOVA for repeated measures will be utilized, employing IBM SPSS Statistics v31.0 software. Any adverse effects will be documented.
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
- •The study participants are individuals aged 18 years and older, encompassing both male and female subjects. These participants are undergoing blepharoplasty and have provided their written informed consent to partake in the research.
排除标准
- •Individuals with a history of previous surgical procedures on the eyelids, apart from the current blepharoplasty. . Those who have previously undergone intralesional modulation are also considered. Individuals with a known allergy to any components of the product under investigation. The presence of local skin infections in the treatment area. Suspicious skin lesions suggestive of malignancy in the eyelid region. Pregnancy or breastfeeding during the study. - Research subjects who, after being included in the study, do not complete the scheduled clinical follow-up. Research subjects who discontinue the use of the topical treatment before the end of the established period. Voluntary withdrawal of informed consent at any stage of the study. Later detection of exclusion criteria that were not identified during the initial evaluation.
研究组 & 干预措施
Improscar Stick® 50, a silicone-based topical formulation with sunscreen (SPF 50) application
干预措施: Silicone-based topical formulation with sunscreen (SPF 50) application (Drug)
结局指标
主要结局
Objetive evaluation
时间窗: From enrollment to the end of treatment at 3 months
To objectively evaluate the quality of post-surgical eyelid scars, assessments will be conducted based on the Vancouver scale, focusing on vascularity, pigmentation, pliability, and height.
Subjective evaluation
时间窗: From enrollment to the end of treatment at 3 months
For subjective evaluation, the POSAS scale will be employed, which consists of two components: one completed by the research subject and the other by the clinical observer. Each component assesses six domains-color, thickness, relief, itching, and pain-using a scoring system ranging from 1 (normal skin) to 10 (worst possible outcome).
次要结局
未报告次要终点