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Efficacy and safety of virgin coconut oil and king coconut oil compared to liquid paraffin as a moisturizer for mild atopic dermatitis: A randomized double-blind study

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SLCTR Registration Number

SLCTR/2021/006


Date of Registration

01 Mar 2021

The date of last modification

Mar 01, 2021



Application Summary


Scientific Title of Trial

Efficacy and safety of virgin coconut oil and king coconut oil compared to liquid paraffin as a moisturizer for mild atopic dermatitis: A randomized double-blind study


Public Title of Trial

Efficacy and safety of virgin coconut oil (generic) and king coconut oil (generic) compared to liquid paraffin (generic) as a moisturizer in patients with mild atopic dermatitis: A randomized double-blind study


Disease or Health Condition(s) Studied

Atopic dermatitis


Scientific Acronym

None


Public Acronym

None


Brief title

Use of coconut oil and king coconut oil as a moisturizer for mild atopic dermatitis


Universal Trial Number

U1111-1260-8710


Any other number(s) assigned to the trial and issuing authority

2020/EC/62; University of Peradeniya


Trial Details


What is the research question being addressed?

Is virgin coconut oil or king coconut oil, efficacious and safe as a moisturizer compared to liquid paraffin in patients with mild atopic dermatitis?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Data analysts, Healthcare providers, Outcome assessors


Control

Active


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

The study population will be recruited from the outpatient dermatology clinic “Skin Center”, Sirimavo Bandaranayake Mawatha, Kandy, Sri Lanka. The study will be conducted at the Department of Pharmacology, Faculty of Medicine, University of Peradeniya as a single center study.

The study will be conducted as a clinical trial with three study arms with a total sample size of 180. Study duration will be 24 months.

Block randomization will be used to ensure that the total sample size of 180 will be equally divided for three treatment options with 60 participants per each. Each block will be of a size 3. The process ensures that each participant within each block is allocated to either treatment “A”, “B” or “C”. Within each block, however the order of patients is random.

There are six different ways that three patients can be split evenly between three treatments:
1. ABC, 2. ACB, 3. BAC, 4. BCA, 5.CAB, 6. CBA The next step is to select randomly amongst these six different blocks for each group of three participants that are recruited. The random selection will be done using a list of random numbers generated using software Microsoft Excel.

Every patient will be given a bottle filled with VCO [generic], king coconut oil [generic], or liquid paraffin [generic] according to the randomization sequence. Pure products will be used without additives. Patients will need to apply the given oil on the skin, twice daily all over the body except on the face.

The bottle contains a dropper and the patient has to put some drops on his/her palms and apply the oil gently over the skin to place a thin film of oil and gently rub. The patient will be asked to take at least one bath or a shower a day in lukewarm (not hot) water for 10 to 15 minutes. Before the treatment, the patient has to have a bath/a shower using the given soap. Oiling routine has to be scheduled in the morning and night.

After bathing, the skin should be patted lightly with a towel leaving it slightly damp. Then within three minutes, the given oil has to be applied liberally all over the body except on the face. The application should be done along the body from proximal to distal. The patient has to wait about 2 minutes to let the oil absorbed into the skin before they get dressed. Oil should be applied on hands every time they are washed or come into contact with water. This treatment will be done twice daily throughout the study period of 4 weeks for each patient.


Inclusion criteria

• Both male and female • Age more than 2 years * Patients diagnosed with atopic dermatitis(AD) defined according to the Hanifin and Rajka criteria f for the diagnosis of AD [Major Criteria: Pruritus, Dermatitis affecting flexural surfaces and the face and extensors in infants, Chronic or relapsing dermatitis, Personal or family history of cutaneous or respiratory atopy Minor criteria: Features of facial pallor or erythema, hypopigmented patches, infraorbital darkening, infraorbital folds or wrinkles, cheilitis, recurrent conjunctivitis and anterior neck folds. Triggers of atopic dermatitis; foods, emotional factors, environmental factors, and skin irritants such as wool, solvents and sweat. Complications of atopic dermatitis: susceptibility to cutaneous viral and bacterial infections, impaired cell mediated immunity, immediate skin-test reactivity, raised serum IgE. Others: early age of onset, dry skin, ichthyosis, hyperlinear palms, keratosis pilaris, hand and foot dermatitis, nipple eczema, white dermatographism and perfollicular accentuation] Diagnosis will be made when there are 3 out of 4 major criteria and 3 out of minor criteria • An Investigator’s Global Assessment (IGA) score of 2, corresponding to mild disease. IGA will be performed by the principal investigator (Consultant Dermatologist).


Exclusion criteria

• Presence of AD only on the face • Patients who are mentally or physically handicapped • Pregnant or lactating women • Patients who had used topical or oral steroids during the past two weeks • Patients who had used topical calcineurin inhibitors during the past two weeks • Patients who had used systemic therapies (Methotrexate, cyclosporine, azathioprine, mycophenolate mofetil [MMF]) during past two weeks • Patients with currently infected lesions that require antibiotics • Patients with dermatological conditions in addition to AD • Patients with hypersensitivity to VCO, king coconut oil or liquid paraffin • Patients with any concomitant medication that could aggravate AD
Medications: retinoids, topical corticosteroids (prolonged use), diuretics, lipid?lowering agents, calcium antagonists, beta-blockers, and rheumatic drugs, contraceptives/antiandrogens, cytostatic agents • Patients with any comorbidity that could aggravate AD Comorbidities: heart failure/ chronic kidney disease/ diabetes mellitus/ hepatopathies (e.g., primary biliary cholangitis, primary sclerotic cholangitis, drug?induced cholestasis, extrahepatic cholestasis)/ hyperparathyroidism/ hypo or hyperthyroidism/ iron deficiency • Patients with any of the following medical conditions Medical conditions: chronic inflammatory bowel disease/ rheumatic diseases/ infections such as diarrheal diseases, helminths, hepatitis B and C virus and HIV/ hematological and lymphoproliferative diseases/ malnutrition due to hypovitaminosis (vitamin D, vitamin A, niacin deficiency), zinc or iron deficiency * Patients using topical steroids and other emollients



Primary outcome(s)

1.

Percentage improvement of mean SCORAD ("SCORing Atopic Dermatitis") using the tool, http://adserver.sante.univ-nantes.fr/Compute.html

[

At base line, end of 2nd and 4th week

]

Secondary outcome(s)

1.

Percentage improvement of mean Patient-Oriented Eczema Measure [POEM] scores using a 7-item questionnaire [https://www.nottingham.ac.uk/research/groups/cebd/documents/methodological-resources/poem-for-proxy-completion.pdf]

[

At base line, end of 2nd and 4th weeks of starting the intervention

]
2.

Percentage improvement of instrumental measurements of skin parameters, skin moisture using a digital moisture monitor, and skin lipid levels in the stratum corneum measured using a skin analyzer.

[

At base line, end of 2nd and 4th weeks

]
3.

Incidence of adverse events using an interviewer administered questionnaire

[

At base line, end of 2nd and 4th weeks

]
4.

Compliance to treatment by assessing diary maintained and remaining medications

[

At two weekly intervals

]

Target number/sample size

180 (3x60)


Countries of recruitment

Sri Lanka


Anticipated start date

2021-03-01


Anticipated end date

2021-03-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals

NA



State of Ethics Review Approval


Status

Approved


Date of Approval

2020-12-12


Approval number

2020/EC/62


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:Ethics Review Committee, Faculty of Medicine, University of Peradeniya, Galaha Road, Kandy, Sri Lanka
Telephone:+94-812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Sanjeewani Fonseka
Senior Lecturer
Department of Pharmacology, Faculty of Medicine, University of Peradeniya, Sri Lanka

+94 718074979

sanjeewani.fonseka@yahoo.com
https://med.pdn.ac.lk/departments/pharmacology/staff/fonseka.html

Contact Person for Public Queries

Dr. Sanjeewani Fonseka
Senior Lecturer
Department of Pharmacology, Faculty of Medicine, University of Peradeniya, Sri Lanka

+94 718074979

sanjeewani.fonseka@yahoo.com
https://med.pdn.ac.lk/departments/pharmacology/staff/fonseka.html


Primary study sponsor/organization

University of Peradeniya





Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

All individual participant data collected during the trial, after de-identification, and individual participant data that underlie the results being reported, after de-identification (text, tables, figures, and appendices) will be shared. The study protocol and the statistical analysis plan will also be shared. Data will be shared within 3 months and the end of 5 years following article publication. Data will be shared among investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve the aims in an approved proposal and for individual participant data meta-analysis. Data will be available by contacting sanjeeewani.fonseka@yahoo.com. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication at the University data warehouse but without investigator support other than deposited meta-data. Information regarding submitting proposals and accessing data may be found by emailing me at sanjeeewani.fonseka@yahoo.com. At the time of maintenance of placement of the data in a data repository, the link will be provided.


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results