atopic dermatitis
Conditions
Interventions
Preparation group of C.acnes of high ILA production:C.acnes of high ILA production
Cream base placebo group:Cream base placebo
Preparation group ILA :Preparation ILA
Preparation group of C.acnes of high ILA production (Healthy people):C.acnes of high ILA production
Cream base placebo group (Healthy people):Cream base placebo
Preparation group ILA (Healthy people):Preparation ILA
Sponsors
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy Control: (1) Aged 12-65 years, gender is not limited; (2) Those who can understand and sign the informed consent form, voluntarily participate in the project and can complete the follow-up as required; (3) the body surface area (BSA) measured by the Mosteller BSA calculator was between 1.26 m^2 and 2.25 m^2; (4) No systemic underlying diseases and skin diseases; Blood, liver and kidney function, blood, urine routine and other examination indicators are all within the normal range. AD patients: (1) Age 12-65 years old, gender is not limited; (2) Patients who meet the Hanifin-Rajka diagnostic criteria and exclude infection, tumors and other connective tissue diseases to diagnose AD; (3) Meet the SCORAD score of 0-40; (4) body surface area (BSA) measured by the Mosteller BSA calculator between 1.26 m2 and 2.25 m2; (5) Skin lesions BSA =5%; (6)Willing to use adequate contraception for the duration of the study and until the completion of participation in the study.
Exclusion criteria
Exclusion criteria: Healthy Control: (1) allergy to external antibiotics (this would preclude treatment of any accidental infection); (2) Have any history of neutrophil count =1.5×10^9/L or white blood cell count =3.0×10^9; (3) Females who are pregnant or lactating, or who wish to become pregnant and/or breastfeed during their participation in the study; (4) Unable or unwilling to provide written informed consent or comply with the study protocol; (5) Have active bacterial, viral or fungal skin infection; (6) Any significant breakage or crack in the skin of the upper limbs, including severely abrased skin or skin with open or oozing wounds, suggesting active infection or increased susceptibility to infection; (7) Allergy to cream matrix; (8) past or current medical problems or results of physical examination or laboratory tests not listed above that, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with the requirements of the study or may affect the quality of data obtained from the study; (9) use of topical glucocorticoid ointment and calcineurin inhibitors within 7 days; (10) Use of any oral or topical antibiotic within 7 days; (11) Oral steroids and immunosuppressants within 4 weeks; (12) Phototherapy for skin diseases (e.g., NB-UVB, UVB, UVA1, PUVA) within 4 weeks; (13) Participated in other interventional clinical studies within 8 weeks; (14) Patients who are addicted to drugs, alcoholism or mental disorders, unable to cooperate or adhere to treatment, and have poor compliance with prediction; (15) Other conditions that the investigator considers unsuitable for enrollment. AD patients: (1) There are other inflammatory skin diseases that may interfere with the evaluation of efficacy, including but not limited to psoriasis, parapsoriasis, eosinophilic dermatitis, seborrheic dermatitis, contact dermatitis, etc.; (2) participants with Netherton syndrome or other inherited skin conditions that result in epidermal barrier defects; (3) Have severe heart, brain, lung, liver, kidney, blood and other important organ system diseases, any immunocompromised (such as lymphoma, infection with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), Wiskott-Aldrich syndrome) or a history of malignant diseases, and the investigator believes that it is not suitable to participate in this study; (4) allergy to external antibiotics (this would preclude treatment of any accidental infection); (5) Have any history of neutrophil count =1.5×109/L or white blood cell count =3.0×109; (6) Females who are pregnant or lactating, or who wish to become pregnant and/or breastfeed during their participation in the study; (7) Participants who are unable or unwilling to provide written informed consent or comply with the study protocol; (8) Have active bacterial, viral or fungal skin infection; (9) Allergy to cream matrix; (10) past or current medical problems or results of physical examination or laboratory tests not listed above that, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with the requirements of the study or may affect the quality of data obtained from the study; (11) use of topical glucocorticoid ointment and calcineurin inhibitors within 7 days; (12) use of any oral or topical antibiotic within 7 days; (13) Taken a bleach
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily event rate of serious and non-serious adverse events (AEs);Achievement of EASI 50 response ratio: the proportion of patients with a 50% decrease in EASI score in this group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with at least one adverse event(AE);Species abundance of C. acnes in lesions on days 0, 7, 14 is measured by culture, expressed in relative colony-forming units per square centimeter (rCFU/cm2).;Species abundance of S. Aureus in lesions on days 0, 7, 14 is measured by culture, expressed in relative colony-forming units per square centimeter (rCFU/cm2).;Skin physiological indicators such as stratum corneum hydration, transepidermal water loss, and sebum content were recorded;Achievement of NRS 50 response ratio: the number of patients with a 50% decrease in NRS score was in this group;Daily event rate of serious and non-serious adverse events (AEs) ;EASI scores on day 7, 14 and 28 ;SCORAD scores on day 7, 14 and 28;NRS scores on day 7, 14 and 28;Species abundance of C.acnes in lesions on days 0, 7, 14,28 is measured by culture, expressed in relative colony-forming units per square centimeter (rCFU/cm2).;Species abundance of S. Aureus in lesions on days 0, 7, 14,28 is measured by culture, expressed in relative colony-forming units per square centimeter (rCFU/cm2).; | — |
Countries
China
Contacts
Public ContactXu Yao
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Outcome results
None listed