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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

Tracking Information
First Submitted Date  ICMJE July 31, 2018
First Posted Date  ICMJE August 6, 2018
Last Update Posted Date August 6, 2018
Actual Study Start Date  ICMJE February 6, 2017
Actual Primary Completion Date May 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Transepidermal water loss (TEWL) [ Time Frame: 14 days ]
    TEWL is the amount of water that passively evaporates through skin to the external environment
  • Skin capacitance [ Time Frame: 14 days ]
    Skin capacitance depends on the water content of the stratum corneum
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
Official Title  ICMJE The Effectiveness and Dermato-pharmacokinetic of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Hand Dermatoses
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Coconut Oil Cream
    This group consist of batik traditional workers who use coconut oil cream for 2 weeks.
    Interventions:
    • Drug: Cocos Nucifera Whole
    • Drug: Cocos Nucifera Whole
  • 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.
    Interventions:
    • Drug: Cocos Nucifera Whole
    • Drug: Cocos Nucifera Whole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2018)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 14, 2018
Actual Primary Completion Date May 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03617068
Other Study ID Numbers  ICMJE 007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data
Responsible Party Fakultas Kedokteran Universitas Indonesia
Study Sponsor  ICMJE Fakultas Kedokteran Universitas Indonesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Retno W Soebaryo, Prof Fakultas Kedokteran Universitas Indonesia
PRS Account Fakultas Kedokteran Universitas Indonesia
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP