Atopic dermatitis
Conditions
Interventions
Crisaborole group:Topical use of Crisaborole, twice a day
Pimecrolimus group:Topical use of Pimecrolimus, twice a day
Sponsors
Shenzhen Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female of appropriate age (2-17 years) at the time of informed consent procedure; 2. The candidate should be diagnosed with AD according to the criteria of Hanifin and Rajka; 3. ISGA of the candidate should be scored 2 (mild) or 3 (moderate) (excluding scalp) at baseline, and the BSA affected is greater than 5%; 4. All participants signed and dated an approved informed consent form, indicating that the participant (or parent/legal guardian) has been informed of all matters related to the study; 5. The participants have to be willing and able to conform to follow-up, treatment plans and other research procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with active or potentially relapsing non-AD skin disease and skin disease genetic overlap with AD (such as Naseton syndrome), or suffering with severe systemic disease such as severe heart, liver, kidney disease or disease with injurious immune system (such as lymphoma, AIDS, Wiskott-Aldrich syndrome); 2. AD patients undergo unstable clinical condition or always requires high-potency or ultra-high topical glucocorticoids to control disease signs and symptoms; 3. A history of angioedema or hypersensitivity reactions; 4. Patients have significant active systemic or local infection, including AD patients with known active infection; 5. Received prohibited drugs/treatments (such as dupilumab) that may change the course of AD and has not performed the required minimum elution or is expected to use prohibited drugs/treatments; 6. The time of surgery or medical procedure of patients overlap with the period of the clinical study (from screening to end of study); 7. History of cancer or received any types of cancer treatment within the last 5 years (except for squamous cell carcinoma, basal cell carcinoma or carcinoma in situ of the skin that clinical cured by cryosurgery or surgical resection); 8. Individuals with known allergies to any component of the study drugs; 9. Individuals are the staff of the research center that directly involved in the implementation of the research or their family members, as well as the staff of the research center who are supervised by the researcher in other manner; 10. Individuals suffering with other acute or chronic medical or psychiatric diseases, including a history of suicidal ideation or behavior, as well as laboratory abnormal examination that may increase the risk associated with participation in research or the administration of investigational drugs, or may interfere with research interpretation of the results, the investigators judge that would render the subject unsuitable for entry into this study, including the following conditions: For subjects aged 7–11, having suicidal ideation in the past six months with actual intent and the answers of starting on item 5 are affirmative, or have a history of suicide in life: The answer to any item related to suicidal behavior in C-SSRS is yes. For subjects 12 years of age and older, with suicidal ideation in the past year and have actual intent and method or plan for suicide: the answer to item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) is affirmative, or history of suicide in the past 5 years: The answer to any item related to suicidal behavior in C-SSRS (events in the past 5 years) is affirmative. For young subjects under 7 years of age, subjects were considered to be at risk for suicidal thoughts and behavior after clinical assessment and communication with their parents/carers; 11. Pregnant or lactating female individuals; the female individuals that have reproductive potential but are unwilling or unable to use an appropriate contraceptive method specified in this study protocol throughout the study period and at least 28 days after the last use of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with Investigator’s Static Global Assessment (ISGA) success; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in EASI (Eczema area and severity index) scores as compared to baseline;Percentage of patients with Investigator’s Static Global Assessment (ISGA) improve;Change from baseline in NRS scores;Investigator’s Static Global Assessment (ISGA) success changes over time;Investigator’s Static Global Assessment (ISGA) improve changes over time;Percentage change in EASI (Eczema area and severity index) scores over time as compared to baseline;Change From Baseline in Total Body Surface Area (BSA) affected ;EASI-50(>=50% overall improvement from baseline) achieved over time;EASI-75(>=75% overall improvement from baseline) achieved over time;Local Investigator’s Static Global Assessment (ISGA)- Facial success over time;Local Investigator’s Static Global Assessment (ISGA)- Facial improve over time;NRS changes over time from baseline -- subjects 12 years and older;Patient-reported itch severity scale scores varied from time to baseline -- subjects 6 years and older and younger than 12 years;Observer-reported changes in itch severity Scale scores over time from baseline -- subjects younger than 6 years;Dermatology Life Quality Index, DLQI;Children's Dermatology Life Quality Index (CDLQI);Infants' Dermatitis Quality of Life Index (IDQoL);The dermatitis family impact questionnaire, DFI; | — |
Countries
China
Contacts
Public ContactPing Li
Shenzhen Children's Hospital
Outcome results
None listed