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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 15, 2019

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

Interventions

  • Other: Niacinamide 4%
    • cream moisturizer
  • Other: Virgin Coconut oil 30%
    • cream moisturizer

Arms, Groups and Cohorts

  • Active Comparator: Niacinamide 4%
    • Niacinamide 4%, applied twice daily for 28 days
  • Active Comparator: Virgin coconut oil 30%
    • Virgin coconut oil 30%, applied twice daily for 28 days

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 58 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yenny Rachmawati, Principal investigator – Indonesia University
  • Overall Official(s)
    • Dermatology and Venereology Departement, Principal Investigator, Fakultas Kedokteran Universitas Indonesia

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