None listed
Conditions
Interventions
Medical Device : The test device used is ATO-CURE (model name PR-ATO-001). It delivers plasma formed by the passage of argon gas through an electric field to the affected areas of atopic dermatitis. T
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women ages between 19 and 75 years old. 2. Diagnosed with atopic dermatitis according to Korean diagnostic criteria for atopy (at least two primary diagnostic criteria, and at least four secondary diagnostic criteria) 3. Atopic dermatitis persisting for at least 24 weeks with more than 5% total body surface area (BSA) 4. Atopic dermatitis classified as mild (IGA score of 2 and EASI score between 1.1 and 7.0) or moderate (IGA score of 3 and EASI score between 7.1 and 21.0) at screening and baseline visit. 5. Patients willing to participate in the trial, comply with treatment and procedures, and visit the trial institution for all observational evaluations. 6. Patients who have listened to explanations about the purpose and method of this clinical trial and voluntarily signed a written consent form.
Exclusion criteria
Exclusion criteria: 1. Atopic dermatitis involving the periocular or genital area 2. Patients with medical history or comorbid conditions that may affect the results. A. Serious skin diseases other than atopic dermatitis (e.g., T-cell lymphoma, allergic contact dermatitis, recurrent herpes, active skin infection, etc.) or extensive scars in the area of atopic dermatitis lesions. B. Active itching due to chronic urticaria, allergic substances, insect bites, etc. C. Uncontrolled hypertension: systolic blood pressure >160 mmHg or diastolic blood pressure 5 times the upper limit of normal. G. Severe kidney disease: serum creatinine > 3 times the upper limit of normal. H. Bleeding tendency: PT and aPTT > 1.5 times the upper limit of normal, I. Other severe comorbidities that the investigator deems inappropriate for participation in the clinical trial (e.g.; heart disease, kidney disease, liver disease, respiratory disease, malignant tumors, immunodeficiency, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in IGA (Investigator's Global Assessment) from baseline at the 6-week post-initial application time point | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in DLQI (Dermatology Life Quality Index) score from baseline at 2, 4, and 6 weeks post-initial application time points;The change in EASI (Eczema Area and Severity Index) score from baseline at 2, 4, and 6 weeks post-initial application time points.;The change in pruritus NRS (Numeric Rating Scale) assessment from baseline at 2, 4, and 6 weeks post-initial application time points.;The frequency of rescue medication usage at 2, 4, and 6 weeks post-initial application;The change in TEWL (Transepidermal Water Loss) from baseline at 2, 4, and 6 weeks post-initial application time points | — |
Countries
Korea, Republic of
Contacts
Public ContactHan Seul Kim
Ajou University Hospital
Outcome results
None listed