NCT03395132

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infected Atopic Dermatitis/Eczema

Interventions

Type	Name	Description
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.
DRUG	Fucidin® cream	The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.
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.
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.

Timeline

• Start date: 2018-07-31
• Primary completion: 2019-05-09
• Completion: 2019-05-09
• First posted: 2018-01-10
• Last updated: 2025-02-24

Locations

15 sites across 1 country: China