Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis/Eczema
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|ClinicalTrials.gov Identifier: NCT03395132|
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infected Atopic Dermatitis/Eczema||Drug: Fucicort® Lipid cream Drug: Fucidin® cream Drug: Fucicort® Lipid cream vehicle Drug: betamethasone (Lianbang Beisong®) cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||In order to keep the trial investigator-blind, packaging and labelling of the outer box will be identical for all investigational medicinal products (IMPs). Handling of individual tubes of IMP will therefore be handled by a designated third person. Individual tubes of IMP will be inaccessible for the (sub)investigator and other trial staff involved in evaluation of subjects and conduct of the trial. Subjects will be instructed to only reveal the IMP to the drug dispenser and not to the trial staff.|
|Official Title:||Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis/Eczema|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||January 14, 2020|
|Estimated Study Completion Date :||January 14, 2020|
Experimental: Fucicort® Lipid cream
Fucicort® Lipid cream is a combination of the antibiotic fusidic acid (20 mg/g) and the corticosteroid betamethasone (1 mg/g (as 17-valerate)). Twice daily for two weeks.
Drug: Fucicort® Lipid cream
The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.
Active Comparator: Fucidin cream +betamethasone cream
The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.
Drug: Fucidin® cream
The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.
Drug: betamethasone (Lianbang Beisong®) cream
The active ingredient of betamethasone (Lianbang Beisong®) cream is Betamethasone hydrate. The pack size of betamethasone (Lianbang Beisong®) cream is 15g.
Placebo Comparator: Vehicle cream
The vehicle cream, also named as Fucicort® Lipid cream vehicle, is the identical cream of Fucicort Lipid cream but without the active ingredient. Twice daily for two weeks.
Drug: Fucicort® Lipid cream vehicle
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 percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15 [ Time Frame: from baseline to 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.
- Investigator's Global Assessment (IGA) at Day 15 [ Time Frame: 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).
- Controlled disease according to IGA [ Time Frame: at Day 15 ]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.
- Proportion of patients with successful bacteriological response [ Time Frame: at Day 15 ]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').
- Adverse event (AE)/serious adverse event (SAE) frequency [ Time Frame: baseline to Day 15 and 14±2 days follow up or until the final outcome is determined ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395132
|Contact: LEO Pharma||(+1) firstname.lastname@example.org|
|Beijing Children's Hospital, Capital Medical University||Not yet recruiting|
|Beijing, Beijing, China, 100045|
|Peking Union Medical College Hospital||Not yet recruiting|
|Beijing, Beijing, China, 100730|
|The First Affiliated Hospital of Chongqing Medical University||Not yet recruiting|
|Chongqing, Chongqing, China, 400016|
|Guangdong General Hospital||Recruiting|
|Guangzhou, Guangzhou, China, 510080|
|Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology||Recruiting|
|Wuhan, Hubei, China, 430030|
|Dermatology Hospital, China Academy of Medicine and Science||Recruiting|
|Nanjing, Jiangsu, China, 210042|
|The First Affiliated Hospital of Soochow University||Not yet recruiting|
|Suzhou, Jiangsu, China, 215006|
|The First Hospital of Dalian Medical University||Not yet recruiting|
|Dalian, Liaoning, China, 116011|
|The Second Hospital of Dalian Medical University||Recruiting|
|Dalian, Liaoning, China, 116023|
|General Hospital of Shenyang Military||Not yet recruiting|
|Shenyang, Liaoning, China, 110000|
|The People's Hospital of Liaoning Province||Recruiting|
|Shenyang, Liaoning, China, 110016|
|The Affiliated Hospital of Qingdao University||Not yet recruiting|
|Qingdao, Shandong, China, 266000|
|Shanghai Huashan Hospital||Recruiting|
|Shanghai, Shanghai, China, 200040|
|Children's Hospital of Shanghai||Not yet recruiting|
|Shanghai, Shanghai, China, 200062|
|Xi'an, Shanxi, China, 710038|
|Children's Hospital, Capital Institute of Pediatrics||Not yet recruiting|
|Beijing, China, 100020|
|Study Director:||Study Director||LEO Pharma|