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

The Effectiveness and Dermato-pharmacokinetic 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.

Study Overview

• Status: Completed
• Conditions: Hand Dermatoses
• Intervention / Treatment: Drug: Cocos Nucifera Whole; Drug: Cocos Nucifera Whole

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Faculty of Medicine Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coconut Oil Cream; This group consist of batik traditional workers who use coconut oil cream for 2 weeks.	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; Other Names: Coconut Oil Cream; Drug: Cocos Nucifera Whole; For dermatopharmacokinetic evaluation using tape/ skin stripping; Other Names: Coconut Oil Cream
Placebo Comparator: Placebo Cream; 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; 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; Drug: Cocos Nucifera Whole; For dermatopharmacokinetic evaluation using tape/ skin stripping; Other Names: Coconut Oil Cream

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Retno W Soebaryo, Prof, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): May 3, 2018
• Study Completion (Actual): May 14, 2018

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatitis; Skin Diseases; Hand Dermatoses
• Other Study ID Numbers: 05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No