Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2021/006
Enrollment
Unknown
Registered
2021-03-01
Start date
2021-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis

Interventions

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 Pharmaco

Sponsors

University of Peradeniya
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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] 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 ] Incidence of adverse events using an interviewer administered questionnaire [At base line, end of 2nd and 4th weeks] Compliance to treatment by assessing diary maintained and remaining medications [ At two weekly intervals ]

Countries

Sri Lanka

Contacts

Public ContactDr. Sanjeewani Fonseka

Senior Lecturer

sanjeewani.fonseka@yahoo.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026