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

Hand Dermatoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617068
• Other study ID #: 05
• Status: Completed
• Phase: Phase 3
• Start date: February 6, 2017
• Est. completion date: May 14, 2018

Study information

• Verified date: June 2018
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 14, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Hand Dermatoses
• Skin Diseases

Intervention

Drug:
• Cocos Nucifera Whole
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
• Cocos Nucifera Whole
For dermatopharmacokinetic evaluation using tape/ skin stripping

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Transepidermal water loss (TEWL)	TEWL is the amount of water that passively evaporates through skin to the external environment	14 days
Secondary	Skin capacitance	Skin capacitance depends on the water content of the stratum corneum	14 days