Multicenter, randomized, pivotal clinical study to evaluate the efficacy and safety of low temperature microwave plasma technology with mild and moderate topical atopic dermatitis
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0007975
- Lead Sponsor
- Medipl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 87
(1) Male or female, 6 to 74 years
(2) patients with a diagnosis of chronic atopic dermatitis based on Hannifin and Rajka criteria over 2years.
(3) patients who have atopic dermatitis lesions with total body surface area(BSA) >5% were included. IGA score 2(mild) or 3(moderate)
(4) patients who have atopic dermatitis with symmetric skin lesions.
(5) patients who agrees to contraception during the entire trial period
(6) patients who understand and comply with the procedure
(7) patients who are able to read, understand and voluntarily sign the ICF
(1) Presence of severe skin diseases or large skin scars that may interfere with study assessments, per investigator judgment
(2) Patients with other medical(liver disease, renal failure, and others), psychotic and neurotic causes that may interfere with study assessments
(3) Patients with a history of topical steroids, Immunosuppressive/immunomodulating drugs or antibiotics for treatment of AD within 7 days of the screening visit
(4) At baseline, patients who are within 1 month of systemic therapy, 2 weeks of topical therapy, 2 months of biologics or 5 half-lives(if known), (whichever is longer)
(5) Patients who used steroids, antibiotics, immunosuppressive/immunomodulating drugs(systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.) as a systemic drug treatment within 1 month before the screening visit.
(patients may continue using stable does of such systemic antihistamines if initiated before the screening visit. It is possible to reduce or stop the dose of the drug, but not increase the dose. )
(6) Treatment with TCS or TCI within 1 week before the baseline visit
(7) Treatment with an investigational drug within 1 month screening visit (if biologics, within 4 months or 5 half-lives, whichever is longer
(8) Treatment with a live (attenuated) vaccine within 3months before the baseline visit
(9) Treatment with biologics as follows
- Any cell-depleting agents : within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer
- Other biologics : within 5 half-lives(if known) or 4 weeks prior to baseline visit, whichever is longer
(10) At baseline, presence of any conditions listed as exclusion criteria
(11) Initiation of treatment of AD with prescription moisturizers or moisturizes containing additives such as hyaluronic acid, urea, or filaggrin degradation products during the screening period(patients may continue using stable doses of such moisturizers if initiated before the screening visit)
(12) Planned or anticipated use of any prohibited medications and procedures during study treatment
(13) Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. (patients may be rescreened after infection resolves)
(14) Planned or anticipated major surgical procedure during the patient’s participation in this study
(15) Pregnant or breastfeeding women, or who disagree with contraception until 4 weeks later from last treatment
(16) History of human immunodeficiency virus(HIV) infection/positive HIV serology or hepatitis B surface antigen (HBsAg)/hepatitis C antibody at screening
(17) History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
(18) Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and(if necessary) laboratory assessment have ruled out active infection before randomization
(19) Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, pose a significant risk to the participant; or in
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with both IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of =2 points at week 6
- Secondary Outcome Measures
Name Time Method Change from baseline to week 4, week 6 in IGA score;Percent change in SCORAD from baseline to week 4, week6 ;Change from baseline to week 4, week 6 in Modified ADAS score