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The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04218500
Recruitment Status : Completed
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Yenny Rachmawati, Indonesia University

Study Description
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Brief Summary:
Occupational hand dermatitis (OHD) often occurs in intensive care unit (ICU) nurses, especially in individuals who are vulnerable due to irritant exposure e.g. hand rub alcohol and repeated hand washing activities. The use of moisturizer is one of the recommendations for skin care in OHD. Niacinamide which has anti-inflammatory effects and can improve the skin barrier function. Virgin coconut oil (VCO) is rich in lipids and lauric acid, and has an occlusive effect. Until now there are no guidelines and reference types of moisturizers for secondary prevention in DTAK.

Condition or disease Intervention/treatment Phase
Contact Dermatitis of Hands Other: Niacinamide 4% Other: Virgin Coconut oil 30% Not Applicable

Detailed Description:
The aim of this study is identify the effectiveness and safety between moisturizing cream containing niacinamide 4% and VCO 30% for secondary prevention of occupational hand dermatitis in ICU nurses This study also measured HECSI , TEWL, and SCap before and after treatment
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There were 46 subjects in the niacinamide 4% arm and 46 subjects in the VCO 30% arm
Masking: Double (Participant, Investigator)
Masking Description:

Both moisturizers have the same physical characteristics, with the same color and odor.

Randomization was carried out by other than researcher (statistical adviser)
Primary Purpose: Prevention
Official Title: Comparison of the Effectiveness and Safety Between Moisturizing Cream Containing Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Hermatitis in Intensive Care Unit Nurses: a Double Blind Randomized Clinical Trial
Actual Study Start Date : September 3, 2019
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Niacinamide 4%
Niacinamide 4%, applied twice daily for 28 days
 Other: Niacinamide 4%
cream moisturizer
Active Comparator: Virgin coconut oil 30%
Virgin coconut oil 30%, applied twice daily for 28 days
 Other: Virgin Coconut oil 30%
cream moisturizer


Outcome Measures
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Primary Outcome Measures :
  1. HECSI [ Time Frame: 14 days ]
    Hand eczema severity index (HECSI) is a score to indicate the severity of hand dermatitis. The range of HECSI score is 0-360. The HECSI score before treatment was expected to be higher than after treatment. Outcome: change of HECSI

  2. HECSI [ Time Frame: 28 days ]
    Hand eczema severity index (HECSI) is a score to indicate the severity of hand dermatitis. The range of HECSI score is 0-360. The HECSI score before treatment was expected to be higher than after treatment. Outcome: change of HECSI

  3. TEWL [ Time Frame: 14 days ]
    Trans Epidermal Waterloss (TEWL) is the primary parameter which measured for the skin barrier function, when the skin barrier is damaged the skin will be disrupted in maintaining water. Passive water diffusion via the Corneal stratum. TEWL is measured in g/h/m2. The TEWL value before treatment was expected to be higher than after treatment. Outcome: change of TEWL

  4. TEWL [ Time Frame: 28 days ]
    Trans Epidermal Waterloss (TEWL) is the primary parameter which measured for the skin barrier function, when the skin barrier is damaged the skin will be disrupted in maintaining water. Passive water diffusion via the Corneal stratum. TEWL is measured in g/h/m2. TEWL value before treatment was expected to be higher than after treatment. Outcome: change of TEWL

  5. SCap [ Time Frame: 14 days ]
    Skin Capasitance (SCap) is a score for skin hidration. SCap can be done with measuring the water level in corneal stratum using non-invasive electric method which measure the capacitance. SCap is measured in Arbitrary Unit (AU). SCap value before treatment was expected to be lower than after treatment. Outcome: change of SCap

  6. SCap [ Time Frame: 28 days ]
    Skin Capasitance (SCap) is a score for skin hidration. SCap can be done with measuring the water level in corneal stratum using non-invasive electric method which measure the capacitance. SCap is measured in Arbitrary Unit (AU). SCap value before treatment was expected to be lower than after treatment. Outcome: change of SCap.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ICU nurses who:

  • Sign the informed consent of the study after receiving explanation before all activity related with this study begin.
  • Has Occupation Hand Dermatitis that fulfill the Mathias criteria with dermatitis severity mild to moderate which the score is 1, 2 or 3 corresponding with Investigator Global Assesment (IGA)
  • Agree to follow the study protocol

Exclusion Criteria:

  • History of allergic or irritate by Niacinamide or VCO or other component in moisturizer
  • Receiving medium to high potency of topical Corticosteroid or systemic immunosupresant therapy or history of oral corticosteroid therapy in the last 1 month
Contacts and Locations
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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): NCT04218500


Locations
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Indonesia
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Dermatology and Venereology Departement Fakultas Kedokteran Universitas Indonesia
More Information
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Responsible Party: Yenny Rachmawati, Principal investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04218500    
Other Study ID Numbers: IndonesiaDV
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yenny Rachmawati, Indonesia University:
Occupational Hand Dermatitis
Moisturizer
Niacinamide
Virgin coconut oil
 HECSI
TEWL
SCap
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
 Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents