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

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

Sponsors

Lead Sponsor: Indonesia University

Source Indonesia University
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

Overall Status Completed
Start Date September 3, 2019
Completion Date December 31, 2019
Primary Completion Date October 15, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
HECSI 14 days
HECSI 28 days
TEWL 14 days
TEWL 28 days
SCap 14 days
SCap 28 days
Enrollment 92
Condition
Intervention

Intervention Type: Other

Intervention Name: Niacinamide 4%

Description: cream moisturizer

Arm Group Label: Niacinamide 4%

Intervention Type: Other

Intervention Name: Virgin Coconut oil 30%

Description: cream moisturizer

Arm Group Label: Virgin coconut oil 30%

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 58 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dermatology and Venereology Departement Principal Investigator Fakultas Kedokteran Universitas Indonesia
Location
Facility: Faculty of Medicine, Universitas Indonesia
Location Countries

Indonesia

Verification Date

September 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Indonesia University

Investigator Full Name: Yenny Rachmawati

Investigator Title: Principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Niacinamide 4%

Type: Active Comparator

Description: Niacinamide 4%, applied twice daily for 28 days

Label: Virgin coconut oil 30%

Type: Active Comparator

Description: Virgin coconut oil 30%, applied twice daily for 28 days

Patient Data No
Study Design Info

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

Primary Purpose: Prevention

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)

Source: ClinicalTrials.gov

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