A Phase Ⅱ Study of Hemay808 for Atopic Dermatitis Patients

Inclusion Criteria:

• ≥18 years old and ≤65 years old, gender is not limited;
• It met the diagnostic criteria for atopic dermatitis (AD) of Hanifin&Rajka, and thehistory of AD before screening was ≥6 months;
• The investigator's overall score (IGA) at the screening period/baseline visit was 2-3;
• The skin lesion area of atopic dermatitis (excluding scalp lesions) is 3%-20% of bodysurface area (BSA) and suitable for local treatment;
• During the study period and within 3 months after the last administration, fertilefemale subjects and male subjects who did not receive vasectomy were required to takeeffective contraceptive measures;
• Those who have full knowledge of the test, participate in the test voluntarily andsign the informed consent.

Exclusion Criteria:

• The lesion area of AD is infected and requires local or systematic treatment withanti-infective drugs, or external administration of strong or potent glucocorticoids (see annex 4) or systematic administration of glucocorticoids to control AD Useing ofsystemic glucocorticoids and/or immunosuppressants within 4 weeks; Or sunbathing,phototherapy (including ultraviolet therapy, photochemotherapy, etc.); Or systematicuse of traditional Chinese medicine or natural medicine for the purpose of treatingatopic dermatitis;
• The AD lesion area was marked, tattooed, or hyperpigmented, and was judged by theinvestigator to interfere with the evaluation of the response to the study's drugtherapy;
• Previous use of systemic or local pde-4 inhibitors;
• Suffering from clinically significant active systemic infections;
• 2 times the normal upper limit of ALT or AST >, or the normal upper limit of Cr and >of renal function (study allowed 1 reexamination, excluded if still not meeting theinclusion requirements);
• Unwilling to limit their excessive uv exposure during the study period (e.g.,sunbathing and/or tanning devices);
• Received the following treatment in the limited time period prior to baselineevaluation:

1. . Received biologic therapy (including intravenous immunoglobulin) within 12weeks or 5 half-lives, whichever is greater;
2. . Use of systemic glucocorticoids and/or immunosuppressants within 4 weeks; Orsunbathing, phototherapy (including ultraviolet therapy, photochemotherapy,etc.); Or systematic use of traditional Chinese medicine or natural medicine forthe purpose of treating atopic dermatitis;
3. . The following treatment was administered within 2 weeks: systemicanti-infective drugs (both oral and intravenous); Or local use of glucocorticoidor local use of calcineurin inhibitor; Local use of traditional Chinese medicineor natural medicine for the purpose of treating atopic dermatitis; Or othertopical drugs for the treatment of atopic dermatitis [zinc oxide oil (paste),black bean oil ointment, doxepin cream, etc.];
4. . Local anti - microbial preparation was used within 1 week;

• Suffering from serious diseases of the central nervous system, cardiovascular system,respiratory system, liver, kidney, gastrointestinal system, urinary system, endocrinesystem or blood system, and the researcher believes that may confused result or affectthe safety of the subjects;
• Suffering from a serious mental illness or other condition that affects researchcompliance and may interfere with the conduct of clinical trials;
• A history of malignant tumor;
• With a history of severe allergic reactions to skin topical preparations (includingangioedema, allergic reactions, etc.) or known allergic reactions to Hemay808accessories;
• Screening people who had a long history of drug abuse or alcohol abuse in the first 6months;
• Female subjects who are suspected to be pregnant, lactating or preparing for pregnancyduring the test;
• The subject plans to undergo surgery requiring hospitalization or surgery during hisor her participation in the study;
• Those who participated in clinical studies of other drugs/devices and usedexperimental drugs/devices within the last 3 months of randomized enrollment;
• Other conditions made the researchers considered inappropriate for the study.