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Study aim
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The aim of this study is to evaluate the effect of topical cholecalciferol in mild to moderate atopic eczema in patients aged 2 to 18 years.
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Design
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To compare the effect of the drug and the placebo, after determining the blood level of vitamin D, the patients will be divided into three groups of a least 10 persons: 1) Patients with vitamin D deficiency who receive oral vitamin D and ointment containing drug. 2) Patients who lack vitamin D deficiency are divided into two groups of drugs and placebo in two-blinded and randomized (using random sequences) models. From the time of admission to study, patients should use topical vitamin D 1,000 units per gram and placebo once a day for 8 weeks. Patients are required to refer to follow-up times at specified times (0,4,8) and after 8 weeks, photos and EASI are recorded.
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Settings and conduct
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Patients refer to Skin and Stem Cell Research Center and Children Medical Center Hospital, after determining the blood level of vitamin D, will divide into three groups of at least 10 persons: 1) Patients with vitamin D deficiency who receive oral vitamin D and ointment containing drug. 2) Patients who lack vitamin D deficiency are divided into two groups of drugs and placebo in two-blinded and randomized (using random sequences) models. From the time of admission to study, patients should use topical vitamin D 1,000 units per gram and placebo once a day for 8 weeks. Patients are required to refer to follow-up times at specified times (0,4,8) and after 8 weeks, photos and EASI are recorded.
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Participants/Inclusion and exclusion criteria
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inclusion criteria: 1) aged 2-18 in both genders 2) discontinuation of topical treatment at least 2 weeks ago and for patients who use systemic therapy, it should be stable for months (at least 2 months) and plaque lesions remain in the use of systemic therapy. 3) mild to moderate eczema; Exclusion criteria: 1) History of allergy to the compounds in the formulation and vitamin D3 derivatives 2) aged over 18 years 3) Hypervitaminosis D 4) hypercalcemia 5) Patients with acute eczema attack 6) The presence of skin infection or malignancy at the treatment site 7) The presence of diseases associated with vitamin D metabolism disorders
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Intervention groups
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Patients in the intervention group should use cholecalciferol 1000 unit per gram ointment once a day for 8 weeks on lesions.
Patients in the control group should use a drug-free ointment once a day for 8 weeks on lesions. The placebo ointment contains 95% vaseline and 5% bee wax
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Main outcome variables
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1) Quality of Life
2) Eczema severity
3) adverse effects