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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

NCT03395132 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-02-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Study Director · LEO Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-05-09
Completion
2019-05-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03395132 on ClinicalTrials.gov