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

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.

Study Overview

• Status: Terminated
• Conditions: Infected Atopic Dermatitis/Eczema
• Intervention / Treatment: Drug: Fucicort® Lipid cream; Drug: Fucidin® cream; Drug: betamethasone (Lianbang Beisong®) cream; Drug: Fucicort® Lipid cream vehicle

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100020
    • Children's Hospital, Capital Institute of Pediatrics
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital, Capital Medical University
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510080
      • Guangdong General Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Dermatology Hospital, China Academy of Medicine and Science
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The First Hospital of Dalian Medical University
    • Dalian, Liaoning, China, 116023
      • The Second Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110016
      • The People's Hospital of Liaoning Province
    • Shenyang, Liaoning, China, 110000
      • The Chinese People's Liberation Army General Hospital Of Northern Theater
  • Shandong
    • Qingdao, Shandong, China, 266000
      • The Affiliated Hospital of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Shanghai Huashan Hospital
    • Shanghai, Shanghai, China, 200062
      • Children's Hospital of Shanghai
  • Shanxi
    • Xi'an, Shanxi, China, 710038
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Active Comparator: Fucidin cream +betamethasone cream; The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.	Drug: Fucidin® cream; The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at Day 15
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.	at Day 15
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').	at Day 15
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.	baseline to Day 15 and 14±2 days follow up or until the final outcome is determined

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Study Director, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): May 9, 2019
• Study Completion (Actual): May 9, 2019

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Anti-Bacterial Agents; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Respiratory System Agents; Anti-Asthmatic Agents; Protein Synthesis Inhibitors; Betamethasone; Fusidic Acid
• Other Study ID Numbers: FCF-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No