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

U

University of Indonesia (UI)

Status

Completed

Conditions

Contact Dermatitis of Hands

Treatments

Other: Niacinamide 4%
Other: Virgin Coconut oil 30%

Study type

Interventional

Funder types

Other

Identifiers

NCT04218500
IndonesiaDV

Details and patient eligibility

About

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.

Full 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

Enrollment

92 patients

Sex

All

Ages

18 to 58 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

92 participants in 2 patient groups

Niacinamide 4%
Active Comparator group
Description:
Niacinamide 4%, applied twice daily for 28 days
Treatment:
Other: Niacinamide 4%
Virgin coconut oil 30%
Active Comparator group
Description:
Virgin coconut oil 30%, applied twice daily for 28 days
Treatment:
Other: Virgin Coconut oil 30%

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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