Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 主要终点
- Patient and Observer Scar Assessment Scale
研究概览
简要总结
The objectives of this study were to evaluate efficacy and safety of silicone cream containing Allium Cepa extract in post-cesarean surgical scars treatment. Post-cesarean surgical scars were equally seperated into 2 parts (left part and right part). Silicone cream containing Allium Cepa extract or commercial scar gel was ramdomly assigned to apply on left part or right part of the scar. They will be applied 2 times per day (morning and evening) for 3 months. Patient and Observer Scar Assessment Scale (POSAS) , Vancouver scar scale (VSS), melanin index, and erythema index (using cutometer) were used for scar evaluation at 0, 1,2,and 3 months. Moreover, adverse effects were also observed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years
- •Have Post-Cesarean Surgical Scars at least 1 month
- •REEDA scale = 0 score
- •Able to read and write Thai
- •Able to follow the research plan
- •Able to meet all the researchers throughout the period of participation in the project
排除标准
- •Apply other topical application at the post-cesarean surgical scars within 2 weeks before participating in the study and during the study
- •There is radiation in the area of the post-cesarean surgical scars
- •Chronic skin diseases such as psoriasis, chronic dermatitis, allergies
- •Immune deficient or use immunosuppressants within 2 weeks before participating in the study and during the study
- •Have a history of silicone allergy or onion extract
结局指标
主要结局
Patient and Observer Scar Assessment Scale
时间窗: 3 months
The range of score is 1 to 10. Noraml skin will be recorded as scale 1. Higher scores mean a worse outcome.
次要结局
- Vancouver scar scale(3 months)
- Melanin index(3 months)
- Erythema index(3 months)
- Adverse effect(3 months)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University