atopic dermatitis
Conditions
Interventions
atopic dermatitis:Ammonia oxidizing bacteria
type 2 diabetes with atopic dermatitis:Ammonia oxidizing bacteria
Sponsors
Shantou Longhu People's Hospita
Eligibility
Sex/Gender
Male
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects were eligible for enrollment in the study if they met the following criteria: 1. Male and female subjects >= 14 years of age; 2. In good general health as determined by a thorough medical history and physical examination, and measurement of vital signs; 3. A clinical diagnosis of mild-to-moderate atopic dermatitis according to the criteria of Hanifin and Rajka; 4. A minimum of 10% and not more than 30% of the subjects' body surface area (BSA) affected by atopic dermatitis (affected was defined by physical examination findings: erythema, edema, scaling, lichenification, excoriation, with the excoriation serving as the physical examination correlate of pruritus); 5. An IGA score of 2 to 3; 6. A history of atopic dermatitis for >= 6 months; 7. Ability to understand and sign a written ICF, which must have been obtained prior to treatment; 8. In addition to meeting the above criteria, patients with type 2 diabetes complicated with atopic dermatitis should also meet the diagnostic criteria of Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition).
Exclusion criteria
Exclusion criteria: Any of the following was to exclude a subject from enrolling in this study: 1. Patients with organ dysfunction; 2. Patients complicated with infectious diseases; 3. Patients with malignant tumor; 4. Patients with autoimmune diseases; 5. Patients allergic to this product; 6. Pregnant and lactating women; 7. Exogenous wind cold and fever; 8. Allergic dermatitis and pruritus patients with Alzheimer's disease; 9. Chronic pruritus due to systemic disease; 10. Conditions requiring inhaled steroids; 11. Concurrent skin disease of such severity in the study area that it could have interfered with the study evaluation; 12. Requirement for topical corticosteroids, topical coal tar, topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy, oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics, glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents, systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within 2 weeks of baseline visit. 13. Current or recent history (<=3 months) of systemic use of Otrexup?, Rasuvo?, Rheumatrex? and Trexall or its generic versions such as methotrexate; 14. Positive serology for human immunodeficiency virus (HIV) at Screening; 15. Positive serology for Hepatitis B virus surface antigen (HBsAg) or Hepatitis C virus (HCV) at Screening; 16. History of renal disease; 17. Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than 5 times the drug's half-life, whichever was longer; 18. Use of any biologic within a period of 5 times its half-life; 19. Use of vinegar or bleach baths within 2 weeks of starting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator Global Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin microbial diversity;IST;Intestinal mircobial diversity; | — |
Countries
China
Contacts
Public ContactZhu Dan
Longhu People's Hospital
Outcome results
None listed