Atopic Dermatitis
Conditions
Interventions
Experimental group:Apply externally Qinglong ointment.
Control Group:External Ointment Furen Compound Cream
Sponsors
Wuhan No. 1 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years, both male and female; (2) Patients diagnosed with AD according to the consensus criteria of the American Academy of Dermatology (2014) and meeting the following conditions: 1) Eczema Area and Severity Index (EASI) =21 at screening and baseline visits, with the severity of lichenification at one lesion =2 points; 2) Body Surface Area (BSA) affected by AD =3% and =10% at screening and baseline visits; 3) Weekly average of daily peak pruritus Numerical Rating Scale (NRS) scores at randomization =4 points; (3) Patients with chronic stable phase rash characteristic of atopic dermatitis; disease duration >1 year; (4) Each center includes mild atopic dermatitis (EASI =7) cases =50% of the total allocated cases; (5) Voluntarily signed the Informed Consent Form (ICF) and able to comply with all study visits and related procedures.
Exclusion criteria
Exclusion criteria: (1) The subject currently has other active dermatological conditions (e.g., psoriasis, scabies) that may affect the assessment of AD; (2) Known allergy to any component of the investigational product; or subjects with the following skin lesion manifestations: (a) local burning or discomfort at the rash site, (b) erosion, exudation, or secondary infection at the rash site, or (c) rash primarily distributed in sensitive areas (e.g., face, genitalia, orifices, etc.); (3) The subject has comorbidities that may require systemic glucocorticoids, immunosuppressive therapy, or other interventions, or conditions that require frequent and active monitoring; (4) Subjects with significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or psychiatric diseases, where the condition is unstable or poorly controlled, as determined by the investigator to be clinically significant. "Clinically significant" is defined as the investigator believing that participation in the study would pose a risk to the subject's safety or that exacerbation of the disease/condition during the study would impact efficacy or safety analyses; (5) At screening, any of the following laboratory parameters exceed the specified thresholds: alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (Cr) > 2 times the upper limit of normal (ULN), fasting blood glucose > 2 times ULN; (6) Subjects planning to undergo major surgery during the study period, including inpatient and outpatient/day surgery; (7) The subject has any of the following circumstances: 1) Use of biologics within 10 weeks before randomization or within 5 half-lives (whichever is longer); 2) Use of targeted inhibitors (e.g., JAK inhibitors), systemic glucocorticoids, cyclosporine, or other immunosuppressive agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, UV therapy, or systemic traditional Chinese medicine (TCM) or Chinese patent medicines for AD (e.g., but not limited to, compound glycyrrhizin, tripterygium glycosides, etc.) within 4 weeks before randomization; use of topical glucocorticoids or calcineurin inhibitors within 2 weeks before randomization; or use of moxibustion, blood-letting cupping, TCM fumigation, or TCM baths within 2 weeks before randomization; 3) Receipt of allergen-specific immunotherapy within the past 6 months; 4) Participation in other clinical trials within the past 3 months or 5 half-lives (whichever is longer) before randomization; (8) Subjects deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Pruritus Numerical Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index;Dermatology Life Quality Index;Body Surface Area;Patient-Oriented Eczema Measure;Absolute Eosinophil Count; | — |
Countries
China
Contacts
Public ContactZeng Xianyu
Wuhan No. 1 Hospital
Outcome results
None listed