The trial is designed to compare the efficacy and safety of Fucicort® Lipid cream with the combination treatment of Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream, or Fucicort® Lipid cream vehicle, when applied twice daily for two weeks. The trial is designed to demonstrate that treatment with Fucicort® Lipid cream is not inferior to the combination treatment with the mono component drugs, Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream and that treatment with Fucicort® Lipid cream is superior to the treatment with Fucicort® Lipid cream vehicle. This is a 3-arm, parallel group, active- and vehicle-controlled trial comparing the efficacy and safety after 14 days treatment of Fucicort® Lipid cream, to Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream, or Fucicort® Lipid cream vehicle, in subjects with clinically infected AD/eczema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.
The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.
The active ingredient of Fucicort® Lipid cream vehicle is the identical cream of Fucicort® Lipid cream but without the active ingredient. The pack size of Fucicort® Lipid cream vehicle is 15g.
The active ingredient of betamethasone (Lianbang Beisong®) cream is Betamethasone hydrate. The pack size of betamethasone (Lianbang Beisong®) cream is 15g.
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangzhou, Guangzhou, China
Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology
Wuhan, Hubei, China
Dermatology Hospital, China Academy of Medicine and Science
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Dalian Medical University
Dalian, Liaoning, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The Chinese People's Liberation Army General Hospital Of Northern Theater
Shenyang, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
...and 5 more locations
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities from baseline to Day 15. The m-EASI is a composite score evaluating the severity of 4 clinical signs (erythema, oedema/induration/papulation, excoriation, and lichenification) and the extent of the disease on each of 3 body regions (upper limbs, trunk, and lower limbs) by use of standard scales. The maximum total score is 64.8, with higher values indicating more severe and/or more extensive condition.
Time frame: from baseline to Day 15
Investigator's Global Assessment (IGA) at Day 15
The IGA of disease severity on the body (trunk and extremities, excluding the hands, head, and neck) will be assessed based on a visual evaluation by use of definitions of severity ranging from 0 (clear) to 5 (very severe).
Time frame: at Day 15
Controlled disease according to IGA
Controlled disease according to IGA at Day 15, defined as subjects having at least 'moderate' disease at baseline achieving 'clear' or 'almost clear' disease severity or subjects having 'mild' disease at baseline achieving 'clear' according to IGA.
Time frame: at Day 15
Proportion of patients with successful bacteriological response
Proportion of patients with successful bacteriological response, defined as pathogens present on target lesion at baseline and either: a) no pathogen present on target lesion at Day 15 ('confirmed eradication') or b) no swab taken at Day 15 as no lesion was evident ('presumptive eradication').
Time frame: at Day 15
Adverse event (AE)/serious adverse event (SAE) frequency
Adverse event (AE)/serious adverse event (SAE) frequency by preferred term. Ongoing (serious or non-serious) AE with a possible, probable, or non-assessable relationship to the IMP at the last visit in the treatment phase. The investigator should follow up on the outcome for 14±2 days or until the final outcome is determined. This follow-up visit can be made either as a phone call or as a regular visit according to the investigator's discretion.
Time frame: baseline to Day 15 and 14±2 days follow up or until the final outcome is determined
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