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

Phase 3

Completed

• Conditions: Hand Dermatoses
• Interventions: Drug: Cocos Nucifera Whole

• Registration Number: NCT03617068
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-02-06
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-14
• Status Verified: 2018-06
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-06
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coconut Oil Cream	Cocos Nucifera Whole	This group consist of batik traditional workers who use coconut oil cream for 2 weeks.
Placebo Cream	Cocos Nucifera Whole	This group consist of batik traditional workers who use placebo cream which contained the vehiculum of the cream; using for 2 weeks.

Primary Outcome Measures

Name	Time	Method
clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil	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

Secondary Outcome Measures

Name	Time	Method
Transepidermal water loss (TEWL)	14 days	TEWL is the amount of water that passively evaporates through skin to the external environment
Skin capacitance	14 days	Skin capacitance depends on the water content of the stratum corneum

Trial Locations

Locations (1)

Faculty of Medicine Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia