Hand DermatosesPhase 3NCT03617068
The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
A Phase 3 study testing Cocos Nucifera Whole in people with Hand Dermatoses, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Hand Dermatoses
- What is being tested?
- Cocos Nucifera Whole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 Feb 2017to 14 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: The Effectiveness and Dermato-pharmacokinetic of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
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.
Read the detailed description
The aim of this study is to measure the effectivenes of coconut oil cream for batik workers who suffer from occupational hand dermatitis. The gloves that used as a protective equipment are made from rubber which have its own limitations. Therefore other interventions are needed to improve barrier skin.
- Conditions
- Hand Dermatoses
- Being tested
- Cocos Nucifera Whole
- Medical subject headings
- Hand Dermatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocos Nucifera WholeDrug
Also called Coconut Oil Cream
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
Cocos Nucifera WholeDrug
Also called Coconut Oil Cream
For dermatopharmacokinetic evaluation using tape/ skin stripping
| Study group | Role | What they receive |
|---|---|---|
| Coconut Oil Cream | Active comparator | This group consist of batik traditional workers who use coconut oil cream for 2 weeks. Receives: 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. Receives: Drug: Cocos Nucifera Whole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (2)
Transepidermal water loss (TEWL)
TEWL is the amount of water that passively evaporates through skin to the external environment
Measured: 14 days
Skin capacitance
Skin capacitance depends on the water content of the stratum corneum
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start6 Feb 2017
- Primary completion3 May 2018
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand DermatosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Batik traditional workers with occupational hand dermatitis using emolient for prevention
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Retno W Soebaryo, Prof, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617068
- Sponsor's protocol ID
- 05
- Status last verified
- Jun 2018
- First submitted
- 31 Jul 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Dermato-pharmacokinetic of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
- ClinicalTrials.gov ID
- NCT03617068
- Acronym / sponsor ID
- 05
- Conditions
- Hand Dermatoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to measure the effectivenes of coconut oil cream for batik workers who suffer from occupational hand dermatitis. The gloves that used as a protective equipment are made from rubber which have its own limitations. Therefore other interventions are needed to improve barrier skin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Batik traditional workers with occupational hand dermatitis using emolient for prevention
| Arm | Type | Receives |
|---|---|---|
| Coconut Oil Cream | Active comparator | Drug: Cocos Nucifera WholeThis group consist of batik traditional workers who use coconut oil cream for 2 weeks. |
| Placebo Cream | Placebo comparator | Drug: Cocos Nucifera WholeThis group consist of batik traditional workers who use placebo cream which contained the vehiculum of the cream; using for 2 weeks. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocos Nucifera WholeAlso: Coconut Oil CreamApplying 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 | Drug | Coconut Oil Cream, Placebo Cream |
| Cocos Nucifera WholeAlso: Coconut Oil CreamFor dermatopharmacokinetic evaluation using tape/ skin stripping | Drug | Coconut Oil Cream, Placebo Cream |
Primary outcome
clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil
Time frame: 14 days
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
2 secondary outcomes
Transepidermal water loss (TEWL)
Time frame: 14 days
Skin capacitance
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Retno W Soebaryo, Prof principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cocos Nucifera Whole in people with Hand Dermatoses, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.