Atopic dermatitis
Conditions
Interventions
Trial Group:0.1% mometasone furoate cream + transfer factor oral solution
Control Group:0.1% mometasone furoate cream + transfer factor oral solution simulant
Sponsors
Southern Medical University Dermatology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: The age range is 18 to 75 years old (inclusive of 18 and 75), with no restrictions on gender ratio; 2. Participants fully understand the purpose, nature, methods of the study, as well as possible adverse reactions. They voluntarily participate and sign the informed consent form before the start; 3. Pregnant women (and their male partners) and male participants (and their female partners) must take effective contraceptive measures throughout the study period and for at least 3 months after the last medication. Participants must have no plans for pregnancy, sperm donation, or egg donation throughout the study period and for at least 3 months after the last medication; 4. During the screening process, participants diagnosed with AD according to the Hanifin-Rajka diagnostic criteria for at least 12 months (Note: If the participants have previous diagnoses such as "eczema" or "dermatitis", and their medical history meets the inclusion criteria and they provide corresponding medical records such as hospital/ outpatient medical records, the participants can be included after being screened by the researchers and judged to meet the diagnostic criteria for AD); 5. Patients with mild to moderate atopic dermatitis (IGA score 2 or 3, body surface area BSA: 3% to 10%).
Exclusion criteria
Exclusion criteria: 1. Those whose test results for various examinations (including physical examination, vital signs, blood routine, urine routine, blood biochemistry, 12-lead electrocardiogram, etc.) show abnormality and have clinical significance, and who, after being judged by the researchers, are not suitable for inclusion in the study; 2. Those whose viral tests (hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus) screening indicates abnormality and has clinical significance; 3. Those who have had serious primary diseases of important organs, including but not limited to gastrointestinal tract, respiratory system, kidney, liver, nervous system, blood, endocrine, tumor, immune, mental or cardiovascular diseases; 4. Those who have undergone trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before the screening, or those who plan to undergo surgery during the study; 5. Those who are allergic to two or more drugs, foods such as milk and pollen, or who are known to be allergic to components of this study drug or similar substances; 6. Those who have participated in other clinical trials and received trial drugs or medical devices within 3 months before the screening, with the date of the last receipt of the trial drug or medical device as the time reference; 7. Those who have received vaccines or plan to receive vaccines within 3 months before the screening; 8. Other situations that the researcher considers unsuitable for inclusion in the study; 9. Those who have other skin conditions that affect the judgment of therapeutic efficacy (such as seborrheic dermatitis, contact dermatitis, psoriasis, acne, scabies, secondary psoriasis, eosinophilic dermatitis, cutaneous T-cell lymphoma, Netherton syndrome, high IgE syndrome, Langerhans cell histiocytosis (LCH), AD-like graft-versus-host disease (GVHD), etc.); 10. Those who do not wish to discontinue the use of the prohibited drugs stipulated in this project before the study (except for stable use of >= one week of antihistamine drugs); 11. Those who have received systemic JAK inhibitors (such as ruxolitinib, upadacitinib, tofacitinib, abetastatin) or IL-4 or IL-13 antagonists within 3 months before the screening, including dupilumab, leronizumab or currolozumab, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of responders with a 75% or greater improvement from baseline in the eczema area and severity index (EASI) on study day 42(ie, EASI 75) ;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with an IGA score of 0 or 1(IGA 0/1) and an improvement of 2 or more points from baseline on study day 14/28/42;Safety indicators: including adverse events (AE) , physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory tests and other abnormalities.;3-month recurrence rate;Changes from baseline in EASI scores on days 14/28/42 were studied;Objective: to study the changes of NRS score of itch degree on Day 14/28/42;The percentage of body surface area (BSA) of lesions on day 14/28/42 was measured;Proportion of responders with a 75% or greater improvement from baseline in the eczema area and severity index (EASI) on study days 14/28;Study proportions of EASI50, EASI90, and EASI 100 responders on Days 14/28/42;Objective: to study the changes of dermatology quality of life scale -DLQI-RRB-LQI) scores on day 14,28 and 42; | — |
Countries
China
Contacts
Public ContactLi Huizhong
Southern Medical University Dermatology Hospital
Outcome results
None listed