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

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ClinicalTrials.gov Identifier: NCT03617068
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hand Dermatoses Drug: Cocos Nucifera Whole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Batik traditional workers with occupational hand dermatitis using emolient for prevention
Masking: Double (Participant, Investigator)
Masking Description: blinding had to be done by Clinical Research Supporting Unit Faculty of Medicine, Universitas Indonesia
Primary Purpose: Prevention
Official Title: The Effectiveness and Dermato-pharmacokinetic of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

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 Name: Coconut Oil Cream

Drug: Cocos Nucifera Whole
For dermatopharmacokinetic evaluation using tape/ skin stripping
Other Name: 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 Name: Coconut Oil Cream

Drug: Cocos Nucifera Whole
For dermatopharmacokinetic evaluation using tape/ skin stripping
Other Name: Coconut Oil Cream




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617068


Locations
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Indonesia
Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta, Indonesia, 10430
Sponsors and Collaborators
Fakultas Kedokteran Universitas Indonesia
Investigators
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Principal Investigator: Retno W Soebaryo, Prof Fakultas Kedokteran Universitas Indonesia

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Responsible Party: Fakultas Kedokteran Universitas Indonesia
ClinicalTrials.gov Identifier: NCT03617068     History of Changes
Other Study ID Numbers: 007
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis
Skin Diseases
Hand Dermatoses