Atopic dermatitis
Conditions
Interventions
B group:Cripiprol ointment and desonide cream
A group:Desonide cream
Sponsors
The University of Hong Kong-Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 6 to 65 years, no gender limit; 2.In line with Hanifin&Rajka atopic dermatitis (AD) diagnostic criteria, AD history before screening >= 6 months; 3.The investigator's overall score (IGA) at the baseline visit was 2-3 points; 4.The area of atopic dermatitis lesions involved at the baseline visit (excluding scalp lesions, but including facial lesions) is 3%-20% of the body surface area (BSA), and the lesions are suitable for localization patients; 5.During the study period and within 3 months after the last administration, female subjects with fertility and male subjects who have not undergone vasectomy should take effective contraceptive measures; 6.Those who fully understand the content of the experiment, voluntarily participate in the experiment, and sign the informed consent form; 7.Willing and able to follow planned visits, treatment plans, laboratory tests and other research procedures.
Exclusion criteria
Exclusion criteria: 1.The AD skin lesion area is accompanied by infection and needs to be treated with local or systemic anti-infective drugs, or requires topical super-strong or strong glucocorticoids or systemic glucocorticoids to control the AD condition; 2.Patients with a history of angioedema or allergic reactions; 3.Accompanied by other active inflammatory skin diseases (such as psoriasis, seborrheic dermatitis, lupus, etc.), which will interfere with the evaluation of the response to study drug treatment by the investigators judgment; AD skin lesions are accompanied by scars, tattoos or hyperpigmentation, and the investigator's judgment will interfere with the evaluation of the response to the study drug treatment; 4.Patients who have used systemic or topical PDE-4 inhibitors in the past; 5.There are currently clinically significant active systemic infections; 6.Laboratory examinations during the screening period showed that ALT or AST > 2 times the upper limit of normal, or renal function Cr > upper limit of normal; 7.Patients who are unwilling to restrict their excessive ultraviolet exposure during the research period (for example, sunbathing and/or using tanning devices); 8.Patients who have received the following treatments within the following limited time before the baseline evaluation: (1) Received biological treatment (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer); (2) The following treatments have been used within 4 weeks: systemic glucocorticoids and/or immunosuppressants; or sunbathing, phototherapy (including ultraviolet therapy, photochemotherapy, etc.); or systemic use for the purpose of treating atopic dermatitis Chinese medicine or natural medicine; (3) The following treatments have been used within 2 weeks: topical use of glucocorticoids or topical calcineurin inhibitors; or topical use of Chinese medicines or natural medicines for the purpose of treating atopic dermatitis; or other topical topical treatments Drugs for atopic dermatitis; (4) Have used topical antimicrobial agents within 1 week. 9.Accompanied by severe central nervous system, cardiovascular, respiratory, liver, kidney, gastrointestinal, urinary, endocrine, or blood system diseases, and the investigator believes that it may confuse the research results or affect the safety of subjects; 10.Suffer from severe mental illness, or other conditions that affect research compliance, which may interfere with the implementation of clinical trials; 11.Patients with a history of malignant tumors; 12.Have a history of severe allergies to skin external preparations (including angioedema, allergic reactions, etc.); 13.Patients with long-term drug abuse or long-term alcohol abuse history within 6 months before screening; 14.Female subjects who are suspected of being pregnant, lactating, or preparing to become pregnant during the trial; 15.Subjects plan to undergo surgical treatment requiring hospitalization; 16.Participated in other drug/device clinical research within 3 months before randomization; 17.Female subjects who have reproductive potential but are unwilling or unable to use an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema area and severity index;Body surface area;Investigator's global assessment;Skin quality of life index questionnaire; | — |
Countries
China
Contacts
Public ContactHou Suchun
The University of Hong Kong-Shenzhen Hospital
Outcome results
None listed