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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Contact Dermatitis of Hands

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There were 46 subjects in the niacinamide 4% arm and 46 subjects in the VCO 30% arm

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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

Randomization was carried out by other than researcher (statistical adviser)

Study Groups

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Niacinamide 4%

Niacinamide 4%, applied twice daily for 28 days

Group Type ACTIVE_COMPARATOR

Niacinamide 4%

Intervention Type OTHER

cream moisturizer

Virgin coconut oil 30%

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

Group Type ACTIVE_COMPARATOR

Virgin Coconut oil 30%

Intervention Type OTHER

cream moisturizer

Interventions

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Niacinamide 4%

cream moisturizer

Intervention Type OTHER

Virgin Coconut oil 30%

cream moisturizer

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No