chronic eczema
Conditions
Interventions
Experimental group:Tazarotene Betasone Cream Treatment
control group:halometasone cream in the treatment
Sponsors
Shenzhen University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1: Age ranges from 18 to 65 years (inclusive) for both sexes; 2: It conforms to the main characteristics of chronic eczema, neurodermatitis or atopic dermatitis in Chinese Clinical Dermatology in chronic stage--thickened and infiltrated patches of different degrees, brownish red or gray, pigmentation, smooth or rough surface or covered with a little pityriform scale, or scab due to scratch, lichen-like changes of different degrees, papules on the periphery, and clear skin lesion boundary; 3: Disease duration >=3 months; 4: Lesion area (BSA) = 3 cm ² and focal plaque thickening of at least moderate (i.e. IGA score >=3); 5: Lifestyle that understands the trial process and is willing to comply with the trial requirements, and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Patients with serious primary diseases such as cardiovascular, renal, pulmonary, hepatic and hematopoietic system and mental disorders may have conditions that affect the safety of subjects and hinder the ability of subjects to complete the trial during the trial; 2: Those with poor compliance, unable to take medication on time, and unable to cooperate with follow-up visits: 3: Eczematous lesion site is complicated with skin infection, skin malignant tumor and other factors (Note: If the skin malignant tumor of the subject is in remission and the curative treatment is completed at least 12 months before screening, the subject can participate in the clinical trial; 4: The patient is unable to self-report or the direct caregiver (relatives, nannies, etc.) is also unclear about the condition; 5: Women who are pregnant, breastfeeding or preparing for pregnancy; 6: Allergic to the investigational drug and related ingredients; 7: Patients who are taking photosensitizing drugs (e.g. tetracyclines, fluoroquinolones, phenothiazines, sulfonamides), patients who are not able to effectively protect the exposed areas (sunscreen clothing or sunscreen above SPF15), and patients whose sunburn has not been relieved. 8: Within 1 month prior to participating in this study or participating in other drug trials; 9: History of alcoholism or drug abuse or any factor affecting compliance; 10: Systemic use of steroids, immunosuppressants, JAK inhibitors within the last 4 weeks; 11: Biological agents such as duprelizumab that are 12 weeks or 5 half-lives prior to baseline, whichever is longer; 12: External use of steroid drugs or calcineurin inhibitors, PDE4 inhibitors, etc. that may affect treatment in the past 2 weeks; 13: There are factors that may affect the efficacy and safety evaluation in the treatment area: such as local tattoos, other inflammatory skin diseases, etc; 14: Laboratory test results at screening had the following levels: white blood cell count 15 ×10^9/L; hemoglobin 2 times the upper reference value; creatinine> 1.5 times the upper reference value; 15: Patients with planned hospitalization/surgery during the trial; 16: Other circumstances considered inappropriate for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 4 weeks of treatment, the effective rate of each group; | — |
Secondary
| Measure | Time frame |
|---|---|
| IGA0/1 ratio of target lesions in test group and control group after 2 weeks and 4 weeks of treatment;Time required for IGA score reduction >=2 points for target lesions;Time to complete resolution of target lesions in test and control groups;Recurrence rate of 4 weeks after drug withdrawal in patients with complete skin lesion regression in test group and control group;Incidence of skin adverse reactions in the test group and control group after 2 weeks and 4 weeks of treatment;IGA0/1 ratio of target lesions in test group and control group after 2 weeks and 4 weeks of treatment;Time required for IGA score reduction >=2 points for target lesions;Time to complete resolution of target lesions in test and control groups;Recurrence rate of 4 weeks after drug withdrawal in patients with complete skin lesion regression in test group and control group;Incidence of skin adverse reactions in the test group and control group after 2 weeks and 4 weeks of treatment; | — |
Countries
China
Contacts
Public ContactMa Li
Shenzhen University General Hospital
Outcome results
None listed