Atopic dermatitis
Conditions
Interventions
Experimental group:Administer 4% specification HY-072808 ointment twice in the morning and evening for 28 days of treatment
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: Selection criteria: 1) 12 years old = Age = 65 years old (calculated based on the date of signing the informed consent form (ICF)), regardless of gender; 2) Individuals diagnosed with atopic dermatitis (AD) who meet the Hanifin&Rajka diagnostic criteria during screening; 3) Individuals with an Overall Investigator Score (IGA) of 2 or 3 during screening and baseline visits; 4) During screening and baseline visits, the affected area of atopic dermatitis lesions (excluding scalp lesions but including facial lesions) is more than 10% of the body surface area (BSA), and the affected area is suitable for local treatment; 5) Subjects with potential fertility (such as women who have menarche or men who have nocturnal emissions) must agree to effective contraceptive measures throughout the entire study period (from signing the ICF to 3 months after the last administration of the investigational drug); 6) The subjects are able to comply with the protocol requirements, voluntarily participate in the trial, and sign a written informed consent form. If the subject is a minor, written informed consent from the guardian is still required.
Exclusion criteria
Exclusion criteria: 1) Suffering from any other skin diseases that may affect the evaluation of experimental results (such as psoriasis, seborrheic dermatitis, lupus erythematosus), or having scars, fetal plaques, tattoos, obvious pigmentation at the skin lesion that may affect the evaluation of skin lesion treatment response; 2) Individuals with unstable atopic dermatitis or who consistently require the use of potent or ultra potent topical corticosteroids to control the signs and symptoms of atopic dermatitis 3) There are currently clinically significant active systemic infections; 4) Individuals who are unwilling to limit their excessive UV exposure during the research period (such as sunbathing and/or using tanning devices); 5) Individuals who received the following treatments within the following limited time frame prior to enrollment: a) Received biologic therapy for AD or other immune disorders (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer); b) Individuals who have used PDE-4 inhibitors systematically or locally within 4 weeks; c) Within 4 weeks, the system has been treated with JAK inhibitors, glucocorticoids, and/or immunosuppressants; d) Within 4 weeks, the system has used traditional Chinese medicine or natural medicines for the purpose of treating atopic dermatitis; e) Those who have undergone sunbathing and phototherapy (including ultraviolet therapy, photochemical therapy, etc.) to treat AD within 4 weeks; f) Within 2 weeks, local use of drugs aimed at treating atopic dermatitis, including local use of glucocorticoids, local use of calcineurin inhibitors, and local use of JAK inhibitors; Or local use of traditional Chinese medicine or natural medicines for the purpose of treating atopic dermatitis; Or other topical drugs for treating atopic dermatitis [zinc oxide oil (paste), black bean distillate oil ointment, etc.]; g) Used systemic anti infective drugs (including oral and intravenous administration) within 2 weeks; h) Used topical antibiotics for the purpose of treating atopic dermatitis within one week; Note: Inhalation, nasal or ocular corticosteroids that have been consistently used for = 14 days before enrollment, and systemic antihistamines that have been consistently used for = 7 days are allowed to be included in the study. 6) Screening for individuals who have used any strong inhibitors or inducers of CYP2C19 or CYP3A4 enzymes within the first 30 days (CYP2C19 strong inhibitors include fluvoxamine, fluconazole, fluoxetine, and thiaclopidine, while strong inducers include Rifampicin; CYP3A4 enzyme strong inhibitors include clarithromycin, itraconazole, ketoconazole, ritonavir, and strong inducers include rifampicin and phenytoin; 7) Accompanied by severe diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system, or blood system, and the researcher believes that it may confuse the research results or affect the safety of the subjects; 8) Suffering from serious mental illness or other conditions that may affect research compliance and interfere with the execution of clinical trials; 9) Individuals with a history of immunological diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriatic arthritis, etc; 10) Screening for individuals with a history of malignant tumors within the first 5 years; 11) Those who plan to undergo s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema area and severity index;Investigator Global Assessment;Numerical Rating Scale;Dermatology Life Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactWei Hu; ChunJun Yang
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed