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
- Conditions
- Atopic dermatitis
- Registration Number
- SLCTR/2021/006
- Lead Sponsor
- niversity of Peradeniya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method