The Safety and Efficacy of Soluble Microneedle Drug Delivery System Combined with Korean Medicine for Ameliorating Dry Skin in Atopic Dermatitis: An Investigator-initiated, Assessor-blinded, Randomized controlled Parallel Trial

aju Dongshin University Korean Medicine Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新: 2022年9月20日

适应症

试验速览

The biodegradable hyaluronic acid microneedle (BHMN) patch combination therapy significantly improved the L-SCORAD index compared with topical medication alone. 2. For VAS score, the BHMN patch combination therapy significantly improved the VAS for skin dryness compared with topical medication alone. However, the BHMN patch combination therapy did not show superiority over the control treatment in the VAS for pruritus. 3. The BHMN patch combination therapy significantly increased skin hydration compared with the control treatment. 4. In addition, the SCORAD index and DLQI also significantly improved, which reflects the improvement in QoL of the participants. 5. Considering that there were no adverse events during the trial, the BHMN patch can be determined to be a safe medical device.

•(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 areas at the limbs in order to compare the efficacy of solitary local external preparation application with combination therapy of local application and soluble microneedle patch.
•(4) Patients who submitted written consent voluntarily.

•(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.
•(6) Liver patients including cirrhosis or liver cancer.
•(7) Kidney patients including acute or 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 investigators decided inadequate.

发起方

aju Dongshin University Korean Medicine Hospital