The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effectiveness and Dermato-pharmacokinetic of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers

Conditions
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Hand Dermatoses

Intervention / Treatment
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* Drug: Cocos Nucifera Whole
* Drug: Cocos Nucifera Whole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Batik traditional workers with occupational hand dermatitis using emolient for prevention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coconut Oil Cream<br>This group consist of batik traditional workers who use coconut oil cream for 2 weeks. | Drug: Cocos Nucifera Whole<br>* Applying the Cocos Nucifera Whole cream for 2 weeks, on both of arms. We evaluated the score of hand dermatitis using Hand Eczema Score Index ( HECSI), transepidermal water loss (TEWL), and Skin capacitance<br>* Other names: Coconut Oil Cream;Drug: Cocos Nucifera Whole<br>* For dermatopharmacokinetic evaluation using tape/ skin stripping<br>* Other names: Coconut Oil Cream;|
| Placebo Comparator: Placebo Cream<br>This group consist of batik traditional workers who use placebo cream which contained the vehiculum of the cream; using for 2 weeks. | Drug: Cocos Nucifera Whole<br>* Applying the Cocos Nucifera Whole cream for 2 weeks, on both of arms. We evaluated the score of hand dermatitis using Hand Eczema Score Index ( HECSI), transepidermal water loss (TEWL), and Skin capacitance<br>* Other names: Coconut Oil Cream;Drug: Cocos Nucifera Whole<br>* For dermatopharmacokinetic evaluation using tape/ skin stripping<br>* Other names: Coconut Oil Cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil | 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 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal water loss (TEWL) | TEWL is the amount of water that passively evaporates through skin to the external environment | 14 days | 
| Skin capacitance | Skin capacitance depends on the water content of the stratum corneum | 14 days |