The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers

NCT03617068 | Completed Phase 3

• 1 other identifier: 05
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Empirically, mosturizer is used to prevent and treat many occupational dermatoses that has skin barrier impairment. Evidence based medicine about the effectivity of mosturizer in occupational dermatoses is limited. Coconut oil is one of traditional substance that is used as a skin care. There is study shows that coconut oil is effective for atopic dermatitis treatment in children. Other studies are needed to assess the effectivity coconut oil mosturizer cream to overcome occupational hand dermatitis.

Conditions

Hand Dermatoses

Outcome Measures

Primary Outcomes (1)

• clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil

  Batik workers who had hand dermatitis was measured using HECSI score before and after intervention with coconut oil cream. They used the cream twice daily for 14 days

  14 days

Secondary Outcomes (2)

• Transepidermal water loss (TEWL)

  14 days

• Skin capacitance

  14 days

Study Arms (2)

Coconut Oil Cream

ACTIVE COMPARATOR

This group consist of batik traditional workers who use coconut oil cream for 2 weeks.

Drug: Cocos Nucifera Whole

Placebo Cream

PLACEBO COMPARATOR

This group consist of batik traditional workers who use placebo cream which contained the vehiculum of the cream; using for 2 weeks.

Drug: Cocos Nucifera Whole

Interventions

Cocos Nucifera Whole DRUG

Applying the Cocos Nucifera Whole cream for 2 weeks, on both of arms. We evaluated the score of hand dermatitis using Hand Eczema Score Index ( HECSI), transepidermal water loss (TEWL), and Skin capacitance

Also known as: Coconut Oil Cream

Coconut Oil Cream; Placebo Cream

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• signing the informed consent document before the study start
• adult population include patients between the ages of 18 and 64 years who work in the dyeing and washing process more than 6 months.
• suffering from occupational hand dermatitis that meet Mathias Criteria.
• willing to obey the research protocol
• willing to fill in diary periodically

You may not qualify if:

• having history of allergy or irritation caused by coconut oil or other mosturizer
• suffering from symptoms including edema, exudation, crust, fissures, liver problems, and signs of infection
• on corticosteroid treatment ( medium to high potency) or on systemic immunosuppressive therapy

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Study Sites (1)

Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Hand Dermatoses

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Retno W Soebaryo, Prof

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: blinding had to be done by Clinical Research Supporting Unit Faculty of Medicine, Universitas Indonesia
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Batik traditional workers with occupational hand dermatitis using emolient for prevention

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: February 6, 2017
• Primary Completion: May 3, 2018
• Study Completion: May 14, 2018
• Last Updated: August 6, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)