The Efficacy of Soluble Microneedle Drug Delivery System Combined for Ameliorating Dry Skin in Atopic Dermatitis: A Control Group (Normal Patch)-used, Investigator-initiated, Assessor-blinded, Randomized Controlled Parallel Trial

aju Dongshin University Korean Medicine Hospital0 个研究点目标入组 15 人开始时间: 待定最近更新: 2022年3月8日

适应症

试验速览

暂无简介。

•Participants should meet all of the following criteria;
•(1) Male and female patients aged 19-60 at the screening visit.
•(2) Atopic dermatitis patients diagnosed by Hanifin and Rajka criteria and have dry skin. Atopic dermatitis can be diagnosed if the patient has more than 3 of 4 major symptoms and 3 of 23 minor symptoms in the Hanifin and Rajka criteria.
•(3) Patients who have 2 similar dry skin lesions in order to compare the efficacy of biodegradable microneedle patch with normal patch.
•(4) Patients who submitted written consent voluntarily.

•The patient who meets any of the following criteria cannot participate in;
•(1) Patients who were taking intensive medication such as antihistamines or steroids.
•(2) Patients who used oral antihistamines, oral antibiotics, oral or topical steroids, systemic photochemotherapy, or other immunosuppressants within 4 weeks before this study begins.
•(3) Patients having systemic infection or taking systemic antibiotic therapy.
•(4) Patients having other severe skin diseases, except atopic dermatitis.
•(5) Patients taking interferon medication, including interferon-alpha and interferon-beta.
•(6) Liver patients, including cirrhosis or liver cancer.
•(7) Kidney patients, including acute/chronic renal failure, or nephrotic syndrome.
•(8) Severe acute cardiovascular patients including heart failure, myocardial infarction, or stroke.
•(9) Patients who took antipsychotics within 3 months before screening.
•(10) Patient who are sensitive to natural products.
•(11) Patients who have an allergy to adhesives.
•(12) Pregnant or nursing women.
•(13) Severe oozing or maceration.
•(14) Others who principal investigator decided inadequate.

发起方

aju Dongshin University Korean Medicine Hospital