Atopic dermatitis
Conditions
Interventions
Low dose group:HY-072808 ointment (2% drug concentration) was used twice daily for 28 days
High dose group:HY-072808 ointment (4% drug concentration) was used twice daily for 28 days
vehicle group:ointment (0% drug concentration) was used twice daily for 28 days
Sponsors
Peking University People's Hospital; China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age>=18 years old and <=65 years old at the time of screening, regardless of sex; 2)Patients diagnosed as atopic dermatitis (AD) according to Hanifin & Rajka criteria; 3)At screening and at baseline visit, the investigator's overall score (IGA) was 2 or 3 points 4) Atopic dermatitis lesional areas involved at screening and at baseline visits (excluding lesions on the scalp, but including lesions on the face) were 5% to 25% of the body surface area (BSA) and the lesional sites were suitable for local treatment; 5)During the study period and up to three months after the last dose, fertile female subjects and vasectomy male subjects were required to use effective contraception 6)Fully understand the content of the trial, voluntary participation in the trial, and signed the informed consent
Exclusion criteria
Exclusion criteria: 1)Have any other skin disease (such as psoriasis, seborrheic dermatitis, lupus) that may affect the activity of the test results, or in the skin lesions have scars, fetal spots, tattoos, obvious pigmentation, etc. will affect the response to the treatment of skin lesions evaluator; 2)Patients with atopic dermatitis who are unstable or who require constant use of strong or super-strong topical glucocorticoid to control the signs and symptoms of atopic dermatitis 3)Currently, there are clinically significant active systemic infections; 4)Those who were reluctant to limit their excessive UV exposure during the study period (for example, sunbathing and/or the use of tanning devices) 5)Patients who received the following treatments within the following defined time periods before randomization: a)Have received biologics for AD or other immune disorders (including Intravenous immunoglobulin) within 12 weeks or 5 half-lives, whichever is longer; b)Systemic or topical use of PDE-4 inhibitors within 4 weeks; c)Systemic use of JAK inhibitors, glucocorticoid Andor immunosuppressants within 4 weeks d)Within 4 weeks after the systemic use of atopic dermatitis for the purpose of the treatment of traditional Chinese medicine or natural medicine e)Within 4 weeks after the Sun Bath, phototherapy (including ultraviolet therapy, photochemotherapy, etc.) treatment of AD f)Topical medications for atopic dermatitis were used within 2 weeks, including topical glucocorticoid, topical calcineurin inhibitors, and topical JAK inhibitors Or local use of traditional Chinese medicine or natural medicine for the purpose of treating atopic dermatitis, or other topical treatment of atopic dermatitis drugs [ zinc oxide oil (paste) , black soybean oil ointment, etc.; g)Systemic anti-infective drugs (oral and intravenous) were used within 2 weeks h)Use of topical antibiotics for the treatment of atopic dermatitis within 1 week; Note: stable use of inhaled or intranasal or ophthalmic glucocorticoid for >=14 days before randomization, and stable use of systemic antihistamines for >=7 days allowed for inclusion in the study 6)With severe central nervous system, cardiovascular, respiratory, liver, kidney, gastrointestinal, urinary, endocrine system or blood diseases, and the researchers think that it may confuse the results of the study or affect the safety of the subjects; 7)Having a serious mental illness or other conditions that affect research compliance that may interfere with the conduct of clinical trials; 8) Patients with a history of malignancy within 5 years before screening 9)Results of screening laboratory tests showed: Alt or AST >=2 times the upper limit of normal, or renal function CR > 1.5 times the upper limit of normal; (the study allowed 1 review and excluded those who still did not meet the inclusion criteria 10)Previous history of severe allergy to topical skin preparations (including Angioedema, anaphylaxis, etc.) or known allergy to relevant excipients of HY-072808 ointment; 11)With alcohol dependence or drug abuse, drug abuse 12)Participants who participated in other drug/device clinical trials and used the trial drug/device within 3 months before randomization; 13)A woman who is pregnant, nursing, or planning to become pregnant during or within 3 months of the end of the trial 14)The researchers believe there are other conditions that may not be appropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema area and severity index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator Global Assessment;Numerical Rating Scale;Dermatology Life Quality Index;Adverse events; | — |
Countries
China
Contacts
Public ContactZhang Jianzhong; Cui Yong
People's Hospital of Peking University; China-Japan Friendship Hospital
Outcome results
None listed