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NCT Number: NCT03617068

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

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.

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Key information

Conditions

Hand Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocos Nucifera Whole

Drug

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

Other names: Coconut Oil Cream

Primary outcomes

  1. clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil

    Time frame: 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 outcomes

  1. Transepidermal water loss (TEWL)

    Time frame: 14 days

    TEWL is the amount of water that passively evaporates through skin to the external environment

  2. Skin capacitance

    Time frame: 14 days

    Skin capacitance depends on the water content of the stratum corneum

Sponsors and collaborators

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2018
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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