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
NCT ID: NCT03395132
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
68 participants
INTERVENTIONAL
2018-07-31
2019-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Fucicort® Lipid cream
The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.
Fucidin cream +betamethasone cream
The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.
Fucidin® cream
The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.
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.
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.
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.
Interventions
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Fucicort® Lipid cream
The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.
Fucidin® cream
The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* A minimum score of 1 for each of the signs in the m-EASI score in at least one of the pre-defined body areas (trunk and/or extremities)
* Subjects between 2 and 65 years of age
Exclusion Criteria
* Subjects with other skin lesions, e.g. scarring, tattoos, or hyperpigmentation on the treatment area that could interfere with assessments
* Clinical findings such as severe heart, liver, kidney and lung deficiency, which will be impacted by the trial procedures at the investigator's discretion
* Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to randomisation at investigator's discretion
* Use of prohibited medication, i.e.
1. Systemic treatment with immunosuppressive or immunomodulating drugs(including Leigongteng) or corticosteroids within 28 days prior to randomisation
2. Use of topical or systemic antibiotics and anti-histamines within 14 days prior to randomisation
3. Phototherapy (e.g. PUVA, UVA or UVB therapy) within 28 days prior to randomisation
4. Topical treatment with immunomodulators (e.g. pimecrolimus, tacrolimus) within 14 days prior to randomisation
5. Topical treatment with corticosteroids or any other topical treatment within 7 days prior to randomisation
6. Use of any non-prescribed systemic or cutaneous medication within 7 days prior to randomisation
7. The use of analgesics at the discretion of the investigator is allowed before and during the trial
2 Years
65 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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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
Tangdu Hospital
Xi'an, Shan'xi, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Children's Hospital, Capital Institute of Pediatrics
Beijing, , China
Countries
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Other Identifiers
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FCF-38
Identifier Type: -
Identifier Source: org_study_id
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