Clinical trial NCT03395132: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Infected Atopic Dermatitis/Eczema
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

  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

Primary outcomes:
measure: The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15
timeFrame: from baseline to Day 15
Secondary outcomes:
measure: Investigator's Global Assessment (IGA) at Day 15
timeFrame: at Day 15
measure: Controlled disease according to IGA
timeFrame: at Day 15
measure: Proportion of patients with successful bacteriological response
timeFrame: at Day 15
measure: Adverse event (AE)/serious adverse event (SAE) frequency
timeFrame: baseline to Day 15 and 14±2 days follow up or until the final outcome is determined
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangzhou
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong Univ. of Science & Technology
state: Hubei
city: Nanjing
country: China
facility: Dermatology Hospital, China Academy of Medicine and Science
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Dalian
country: China
facility: The First Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The Chinese People's Liberation Army General Hospital Of Northern Theater
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shanxi
city: Beijing
country: China
facility: Children's Hospital, Capital Institute of Pediatrics
Study officials:
affiliation: LEO Pharma
name: Study Director
role: STUDY_DIRECTOR
References: