None listed
Conditions
Interventions
Medical Device : The medical device used in this study is a microneedle patch made up of medical hyaluronic acid microneedles on the hydrocolloid substrate film. If the patch is attached on the skin,
Sponsors
Naju Dongshin University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of skin lesion by comparing photos on the 2nd week with the baseline;Change in L-SCORAD index on the 2nd week from the baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS score for pruritus on the 2nd week from the baseline;Change in VAS score for skin dryness on the 2nd week from the baseline;Change in skin hydration on the 2nd week from the baseline;Change in transepidermal water loss on the 2nd week from the baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Hoon Song
Dongshin University
Outcome results
None listed