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 | Terminated Phase 3 DMC

• 1 other identifier: FCF-38
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 15

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.

Conditions

Infected Atopic Dermatitis/Eczema

Outcome Measures

Primary Outcomes (1)

• 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.

  from baseline to Day 15

Secondary Outcomes (4)

• Investigator's Global Assessment (IGA) at Day 15

  at Day 15

• Controlled disease according to IGA

  at Day 15

• Proportion of patients with successful bacteriological response

  at Day 15

• Adverse event (AE)/serious adverse event (SAE) frequency

  baseline to Day 15 and 14±2 days follow up or until the final outcome is determined

Study Arms (3)

Fucicort® Lipid cream

EXPERIMENTAL

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.

Drug: Fucicort® Lipid cream

Fucidin cream +betamethasone cream

ACTIVE COMPARATOR

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

Drug: Fucidin® cream; Drug: betamethasone (Lianbang Beisong®) cream

Vehicle cream

PLACEBO COMPARATOR

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.

Drug: Fucicort® Lipid cream vehicle

Interventions

Fucicort® Lipid cream DRUG

The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.

Fucicort® Lipid cream

Fucidin® cream DRUG

The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.

Fucidin cream +betamethasone cream

Fucicort® Lipid cream vehicle DRUG

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.

Vehicle cream

betamethasone (Lianbang Beisong®) cream DRUG

The active ingredient of betamethasone (Lianbang Beisong®) cream is Betamethasone hydrate. The pack size of betamethasone (Lianbang Beisong®) cream is 15g.

Fucidin cream +betamethasone cream

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (15)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Guangdong General Hospital

Guangzhou, Guangzhou, 510080, China

Location

Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology

Wuhan, Hubei, 430030, China

Location

Dermatology Hospital, China Academy of Medicine and Science

Nanjing, Jiangsu, 210042, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

Location

The Chinese People's Liberation Army General Hospital Of Northern Theater

Shenyang, Liaoning, 110000, China

Location

The People's Hospital of Liaoning Province

Shenyang, Liaoning, 110016, China

Location

Tangdu Hospital

Xi'an, Shan'xi, 710038, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Shanghai Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Children's Hospital of Shanghai

Shanghai, Shanghai Municipality, 200062, China

Location

Children's Hospital, Capital Institute of Pediatrics

Beijing, 100020, China

Location

MeSH Terms

Conditions

Eczema

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Study Director

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 10, 2018
• Study Start: July 31, 2018
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: February 24, 2025

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)