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

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.

• 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).

• 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