[Translation] Comparison of the efficacy and safety of betamethasone fusidate cream with fusidic acid and betamethasone cream combined with excipients in the treatment of infectious AD/eczema

研究中国人群使用夫西地酸倍他米松乳膏的有效性和安全性。旨在证实夫西地酸倍他米松乳膏不劣于阳性对照剂(夫西地酸乳膏及倍他米松乳膏联合使用)，且优于夫西地酸倍他米松乳膏赋形剂。本试验将获得中国人群使用夫西地酸倍他米松乳膏治疗躯干和四肢(除外面部、颈部和头部)感染性特应性皮炎/湿疹时其安全性和有效性数据。

[Translation]

To investigate the efficacy and safety of betamethasone fusidate cream in the Chinese population. The aim is to demonstrate that betamethasone fusidate cream is non-inferior to the active control (combination of fusidic acid cream and betamethasone cream) and superior to the vehicle of betamethasone fusidate cream. This trial will obtain data on the safety and efficacy of betamethasone fusidate cream in the Chinese population for the treatment of infectious atopic dermatitis/eczema on the trunk and limbs (excluding the face, neck, and head).

Start Date03 Aug 2018

Sponsor / Collaborator

LEO Laboratories Ltd.

[+1]

NCT03395132 / TerminatedPhase 3

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

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.

Start Date31 Jul 2018

Sponsor / Collaborator

Leo Pharma, Inc.

100 Clinical Results associated with Fusidic acid/Betamethasone

100 Translational Medicine associated with Fusidic acid/Betamethasone

100 Patents (Medical) associated with Fusidic acid/Betamethasone

100 Deals associated with Fusidic acid/Betamethasone

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Skin Diseases	CA	Leo Pharma, Inc.	12 Apr 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 3	CN	LEO Pharma A/S	03 Jul 2018
Eczema	Phase 3	CN	LEO Pharma A/S	03 Jul 2018

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