Back to resultsThe Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis
Primary Purpose
Contact Dermatitis of Hands
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Niacinamide 4%
Virgin Coconut oil 30%
Sponsored by
About this trial
This is an interventional prevention trial for Contact Dermatitis of Hands focused on measuring Occupational Hand Dermatitis, Moisturizer, Niacinamide, Virgin coconut oil, HECSI, TEWL, SCap
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
Sites / Locations
- Faculty of Medicine, Universitas Indonesia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Niacinamide 4%
Virgin coconut oil 30%
Arm Description
Niacinamide 4%, applied twice daily for 28 days
Virgin coconut oil 30%, applied twice daily for 28 days
Outcomes
Primary Outcome Measures
HECSI
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
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
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
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04218500
Brief Title
The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis of Hands
Keywords
Occupational Hand Dermatitis, Moisturizer, Niacinamide, Virgin coconut oil, HECSI, TEWL, SCap
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There were 46 subjects in the niacinamide 4% arm and 46 subjects in the VCO 30% arm
Masking
ParticipantInvestigator
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)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Niacinamide 4%
Arm Type
Active Comparator
Arm Description
Niacinamide 4%, applied twice daily for 28 days
Arm Title
Virgin coconut oil 30%
Arm Type
Active Comparator
Arm Description
Virgin coconut oil 30%, applied twice daily for 28 days
Intervention Type
Other
Intervention Name(s)
Niacinamide 4%
Intervention Description
cream moisturizer
Intervention Type
Other
Intervention Name(s)
Virgin Coconut oil 30%
Intervention Description
cream moisturizer
Primary Outcome Measure Information:
Title
HECSI
Description
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
Time Frame
14 days
Title
HECSI
Description
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
Time Frame
28 days
Title
TEWL
Description
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
Time Frame
14 days
Title
TEWL
Description
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
Time Frame
28 days
Title
SCap
Description
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
Time Frame
14 days
Title
SCap
Description
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.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dermatology and Venereology Departement
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Universitas Indonesia
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness and Safety of Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis
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