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

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT04218500

Collaborator

(none)

Enrollment

Location

Arms

3.9

Actual Duration (Months)

23.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contact Dermatitis of Hands	Other: Niacinamide 4% Other: Virgin Coconut oil 30%	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

92 participants

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% armThere 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

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

Actual Study Start Date :

Sep 3, 2019

Actual Primary Completion Date :

Oct 15, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Niacinamide 4% Niacinamide 4%, applied twice daily for 28 days	Other: Niacinamide 4% cream moisturizer
Active Comparator: Virgin coconut oil 30% Virgin coconut oil 30%, applied twice daily for 28 days	Other: Virgin Coconut oil 30% cream moisturizer

Arm

Intervention/Treatment

Active Comparator: Niacinamide 4%

Niacinamide 4%, applied twice daily for 28 days

Other: Niacinamide 4%

cream moisturizer

Active Comparator: Virgin coconut oil 30%

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

Other: Virgin Coconut oil 30%

cream moisturizer

Outcome Measures

Primary Outcome Measures

HECSI [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 58 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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