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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: May 9, 2019

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.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Fucidin cream +betamethasone cream
    • The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of AD/eczema as defined by Williams's criteria with clinical signs of infected AD/eczema on trunk and/or extremities such as fluid drainage, blistered skin, white or yellow pus, severe itchiness and new burning sensation
  • 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

  • History of concurrent diseases that could interfere with trial assessments or pose a safety concern
  • 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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, LEO Pharma

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