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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

Primary Purpose

Infected Atopic Dermatitis/Eczema

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fucicort® Lipid cream
Fucidin® cream
Fucicort® Lipid cream vehicle
betamethasone (Lianbang Beisong®) cream
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infected Atopic Dermatitis/Eczema

Eligibility Criteria

2 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Children's Hospital, Capital Medical University
  • Peking Union Medical College Hospital
  • Guangdong General Hospital
  • Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology
  • Dermatology Hospital, China Academy of Medicine and Science
  • The First Affiliated Hospital of Soochow University
  • The First Hospital of Dalian Medical University
  • The Second Hospital of Dalian Medical University
  • The Chinese People's Liberation Army General Hospital Of Northern Theater
  • The People's Hospital of Liaoning Province
  • The Affiliated Hospital of Qingdao University
  • Shanghai Huashan Hospital
  • Children's Hospital of Shanghai
  • Tangdu Hospital
  • Children's Hospital, Capital Institute of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Fucicort® Lipid cream

Fucidin cream +betamethasone cream

Vehicle cream

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at 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 Outcome Measures

Investigator's Global Assessment (IGA) 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
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
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
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.

Full Information

First Posted
January 3, 2018
Last Updated
May 20, 2019
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03395132
Brief Title
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
Official Title
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
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to business strategic reasons, LEO Pharma has decided to close down the FCF-38 trial.
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
May 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infected Atopic Dermatitis/Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
In order to keep the trial investigator-blind, packaging and labelling of the outer box will be identical for all investigational medicinal products (IMPs). Handling of individual tubes of IMP will therefore be handled by a designated third person. Individual tubes of IMP will be inaccessible for the (sub)investigator and other trial staff involved in evaluation of subjects and conduct of the trial. Subjects will be instructed to only reveal the IMP to the drug dispenser and not to the trial staff.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fucicort® Lipid cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Fucidin cream +betamethasone cream
Arm Type
Active Comparator
Arm Description
The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.
Arm Title
Vehicle cream
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fucicort® Lipid cream
Intervention Description
The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.
Intervention Type
Drug
Intervention Name(s)
Fucidin® cream
Intervention Description
The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.
Intervention Type
Drug
Intervention Name(s)
Fucicort® Lipid cream vehicle
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
betamethasone (Lianbang Beisong®) cream
Intervention Description
The active ingredient of betamethasone (Lianbang Beisong®) cream is Betamethasone hydrate. The pack size of betamethasone (Lianbang Beisong®) cream is 15g.
Primary Outcome Measure Information:
Title
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15
Description
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.
Time Frame
from baseline to Day 15
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA) at Day 15
Description
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).
Time Frame
at Day 15
Title
Controlled disease according to IGA
Description
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.
Time Frame
at Day 15
Title
Proportion of patients with successful bacteriological response
Description
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').
Time Frame
at Day 15
Title
Adverse event (AE)/serious adverse event (SAE) frequency
Description
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.
Time Frame
baseline to Day 15 and 14±2 days follow up or until the final outcome is determined

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Systemic treatment with immunosuppressive or immunomodulating drugs(including Leigongteng) or corticosteroids within 28 days prior to randomisation Use of topical or systemic antibiotics and anti-histamines within 14 days prior to randomisation Phototherapy (e.g. PUVA, UVA or UVB therapy) within 28 days prior to randomisation Topical treatment with immunomodulators (e.g. pimecrolimus, tacrolimus) within 14 days prior to randomisation Topical treatment with corticosteroids or any other topical treatment within 7 days prior to randomisation Use of any non-prescribed systemic or cutaneous medication within 7 days prior to randomisation The use of analgesics at the discretion of the investigator is allowed before and during the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100045
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Dermatology Hospital, China Academy of Medicine and Science
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
The First Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116023
Country
China
Facility Name
The Chinese People's Liberation Army General Hospital Of Northern Theater
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
The People's Hospital of Liaoning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Shanghai Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Children's Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Facility Name
Children's Hospital, Capital Institute of Pediatrics
City
Beijing
ZIP/Postal Code
100020
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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