Clinical Trial to Evaluate the Safety and Efficacy of Theraphytoabel Theraphyto Intensive-Cure Ointment Product in Mild and Moderate Atopic Dermatitis Patients at Vinmec International Hospital Times City
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
Atopic dermatitis (AD) is a chronic skin disorder, which negatively impacts up to 20% children and 3% adults in the world. The main AD treatments aim to regress clinical manifestations, improve and restore skin lesions. Daily moisturizing has also been shown to have the ability to protect the skin, increase skin elasticity and reduce the severity of AD. In the past few decades, Korea has been a well-known country with cosmetic companies and products derived from nature. Carboexpert is also one of them. Since its inception, the company has focused on researching and developing herbal extracts in skin care cosmetic products, typically the product Theraphytoabel Theraphyto Intensive-Cure Ointment. The product uses a high concentration of extract from Syzygium formosum (Wall) masam leaves originating from Vietnam. This is a medicinal herb that has been used in Vietnam for hundreds of years. Folk remedies in Vietnam use hot water leaf extract of this plant to treat urticaria and rashes. Previous studies have shown that leaf extract has also been shown to be very effective against gram-positive bacteria. The study in 2018 also demonstrated that the ethanol extract of S. formosum leaves was effective in reducing food allergy on mouse model. Based on the above evidences, this study will evaluate and compare the effectiveness and safety between Theraphytoabel Theraphyto Intensive-Cure Ointment product and commercial moisturizers which using in Vinmec on moderate and mild AD patients at Vinmec International Hospital Times City, Hanoi.
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
- None
入排标准
- 年龄范围
- 1 Year 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 and 30 years of age
- •Definitive diagnosis of AD according to the Hanifin and Rajka criteria SCORAD scores: < 25: mild AD, 26- 50: moderate AD
- •Total IgE and eosinophil measurements could be performed to access disease severity
排除标准
- •Non-adherence to therapy
- •Presence of other active skin diseases
- •Severe AD within 1 month prior to enrollment
- •Any concomitant disease that in the investigators' judgment, could interdere with treatment
- •Current systemic treatment or use of immunosuppressive or immunomodulatory agents
研究者
Nguyen Thi Minh Nguyet
Medical Research Specialist, assistant professor
VinUniversity
