The Effectiveness and Dermato-pharmacokinetic of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil
研究概览
简要总结
Empirically, mosturizer is used to prevent and treat many occupational dermatoses that has skin barrier impairment. Evidence based medicine about the effectivity of mosturizer in occupational dermatoses is limited. Coconut oil is one of traditional substance that is used as a skin care. There is study shows that coconut oil is effective for atopic dermatitis treatment in children. Other studies are needed to assess the effectivity coconut oil mosturizer cream to overcome occupational hand dermatitis.
详细描述
The aim of this study is to measure the effectivenes of coconut oil cream for batik workers who suffer from occupational hand dermatitis. The gloves that used as a protective equipment are made from rubber which have its own limitations. Therefore other interventions are needed to improve barrier skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
blinding had to be done by Clinical Research Supporting Unit Faculty of Medicine, Universitas Indonesia
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •signing the informed consent document before the study start
- •adult population include patients between the ages of 18 and 64 years who work in the dyeing and washing process more than 6 months.
- •suffering from occupational hand dermatitis that meet Mathias Criteria.
- •willing to obey the research protocol
- •willing to fill in diary periodically
排除标准
- •having history of allergy or irritation caused by coconut oil or other mosturizer
- •suffering from symptoms including edema, exudation, crust, fissures, liver problems, and signs of infection
- •on corticosteroid treatment ( medium to high potency) or on systemic immunosuppressive therapy
研究组 & 干预措施
Coconut Oil Cream
This group consist of batik traditional workers who use coconut oil cream for 2 weeks.
干预措施: Cocos Nucifera Whole (Drug)
Placebo Cream
This group consist of batik traditional workers who use placebo cream which contained the vehiculum of the cream; using for 2 weeks.
干预措施: Cocos Nucifera Whole (Drug)
结局指标
主要结局
clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil
时间窗: 14 days
Batik workers who had hand dermatitis was measured using HECSI score before and after intervention with coconut oil cream. They used the cream twice daily for 14 days
次要结局
- Transepidermal water loss (TEWL)(14 days)
- Skin capacitance(14 days)