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

• ClinicalTrials.gov Identifier: NCT04218500
• Recruitment Status: Completed
• First Posted: January 6, 2020
• Last Update Posted: January 6, 2020
• Sponsor: Indonesia University
• Information provided by (Responsible Party): Yenny Rachmawati, Indonesia University

Tracking Information

• First Submitted Date: January 2, 2020
• First Posted Date: January 6, 2020
• Last Update Posted Date: January 6, 2020
• Actual Study Start Date: September 3, 2019
• Actual Primary Completion Date: October 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2020)

• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Contact Dermatitis of Hands

Intervention

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

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 3, 2020): 92
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 31, 2019
• Actual Primary Completion Date: October 15, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 58 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT04218500
• Other Study ID Numbers: IndonesiaDV
• Has Data Monitoring Committee: No

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

• Plan to Share IPD: No

• Current Responsible Party: Yenny Rachmawati, Indonesia University
• Original Responsible Party: Same as current
• Current Study Sponsor: Indonesia University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dermatology and Venereology Departement; Fakultas Kedokteran Universitas Indonesia

• PRS Account: Indonesia University
• Verification Date: September 2019