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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

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ClinicalTrials.gov Identifier: NCT03395132
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.

Condition or disease Intervention/treatment Phase
Infected Atopic Dermatitis/Eczema Drug: Fucicort® Lipid cream Drug: Fucidin® cream Drug: Fucicort® Lipid cream vehicle Drug: betamethasone (Lianbang Beisong®) cream Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : January 14, 2020
Estimated Study Completion Date : January 14, 2020


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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.

  3. 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').

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395132


Contacts
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Contact: LEO Pharma (+1) 877-557-1168 disclosure@leo-pharma.com

Locations
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China, Beijing
Beijing Children's Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100045
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100730
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China, 400016
China, Guangzhou
Guangdong General Hospital Recruiting
Guangzhou, Guangzhou, China, 510080
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology Recruiting
Wuhan, Hubei, China, 430030
China, Jiangsu
Dermatology Hospital, China Academy of Medicine and Science Recruiting
Nanjing, Jiangsu, China, 210042
The First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, Jiangsu, China, 215006
China, Liaoning
The First Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China, 116011
The Second Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116023
General Hospital of Shenyang Military Not yet recruiting
Shenyang, Liaoning, China, 110000
The People's Hospital of Liaoning Province Recruiting
Shenyang, Liaoning, China, 110016
China, Shandong
The Affiliated Hospital of Qingdao University Not yet recruiting
Qingdao, Shandong, China, 266000
China, Shanghai
Shanghai Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Children's Hospital of Shanghai Not yet recruiting
Shanghai, Shanghai, China, 200062
China, Shanxi
Tangdu Hospital Recruiting
Xi'an, Shanxi, China, 710038
China
Children's Hospital, Capital Institute of Pediatrics Not yet recruiting
Beijing, China, 100020
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Study Director LEO Pharma

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03395132     History of Changes
Other Study ID Numbers: FCF-38
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Fusidic Acid
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action