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临床试验/SLCTR/2021/006
SLCTR/2021/006尚未招募未知

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

niversity of Peradeniya0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 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).

排除标准

  • 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
  • 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

研究者

发起方
niversity of Peradeniya

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