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

Not Applicable

Completed

• Conditions: Contact Dermatitis of Hands
• Interventions: Other: Niacinamide 4%; Other: Virgin Coconut oil 30%

• Registration Number: NCT04218500
• Lead Sponsor: 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

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09-03
• Primary Completion: 2019-10-15
• Study Completion: 2019-12-31
• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-03
• Last Update Submitted: 2020-01-03
• Study First Posted: 2020-01-06
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niacinamide 4%	Niacinamide 4%	Niacinamide 4%, applied twice daily for 28 days
Virgin coconut oil 30%	Virgin Coconut oil 30%	Virgin coconut oil 30%, applied twice daily for 28 days

Primary Outcome Measures

Name	Time	Method
HECSI	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	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	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.

Trial Locations

Locations (1)

Faculty of Medicine, Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia