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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04218500
Enrollment
92
Registered
2020-01-06
Start date
2019-09-03
Completion date
2019-12-31
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Dermatitis of Hands

Keywords

Occupational Hand Dermatitis, Moisturizer, Niacinamide, Virgin coconut oil, HECSI, TEWL, SCap

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

Interventions

OTHERNiacinamide 4%

cream moisturizer

OTHERVirgin Coconut oil 30%

cream moisturizer

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, 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)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 58 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HECSI14 daysHand 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
TEWL14 daysTrans 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
SCap14 daysSkin 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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026