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

Primary Purpose

Hand Dermatoses

Status

Completed

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Cocos Nucifera Whole

About this trial

This is an interventional prevention trial for Hand Dermatoses

Eligibility Criteria

25 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Medicine Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Coconut Oil Cream

Placebo Cream

Arm Description

This group consist of batik traditional workers who use coconut oil cream for 2 weeks.

This group consist of batik traditional workers who use placebo cream which contained the vehiculum of the cream; using for 2 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Transepidermal water loss (TEWL)

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

Skin capacitance

Skin capacitance depends on the water content of the stratum corneum

Full Information

NCT ID

NCT03617068

First Posted

July 31, 2018

Last Updated

August 5, 2019

Sponsor

Fakultas Kedokteran Universitas Indonesia

1. Study Identification

Unique Protocol Identification Number

NCT03617068

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

February 6, 2017 (Actual)

Primary Completion Date

May 3, 2018 (Actual)

Study Completion Date

May 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fakultas Kedokteran Universitas Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand Dermatoses

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Model Description

Batik traditional workers with occupational hand dermatitis using emolient for prevention

Masking

ParticipantInvestigator

Masking Description

blinding had to be done by Clinical Research Supporting Unit Faculty of Medicine, Universitas Indonesia

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Coconut Oil Cream

Arm Type

Active Comparator

Arm Description

This group consist of batik traditional workers who use coconut oil cream for 2 weeks.

Arm Title

Placebo Cream

Arm Type

Placebo Comparator

Arm Description

This group consist of batik traditional workers who use placebo cream which contained the vehiculum of the cream; using for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

Cocos Nucifera Whole

Other Intervention Name(s)

Coconut Oil Cream

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cocos Nucifera Whole

Other Intervention Name(s)

Coconut Oil Cream

Intervention Description

For dermatopharmacokinetic evaluation using tape/ skin stripping

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Transepidermal water loss (TEWL)

Description

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

Time Frame

14 days

Title

Skin capacitance

Description

Skin capacitance depends on the water content of the stratum corneum

Time Frame

14 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Retno W Soebaryo, Prof

Organizational Affiliation

Fakultas Kedokteran Universitas Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Universitas Indonesia

City

Jakarta Pusat

State/Province

Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to make individual participant data

Learn more about this trial

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

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