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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- LEO Pharma
- 入组人数
- 68
- 试验地点
- 15
- 主要终点
- The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fucidin cream +betamethasone cream
The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.
干预措施: betamethasone (Lianbang Beisong®) cream (Drug)
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.
干预措施: Fucicort® Lipid cream (Drug)
Fucidin cream +betamethasone cream
The combination treatment with Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream. Twice daily for two weeks.
干预措施: Fucidin® cream (Drug)
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.
干预措施: Fucicort® Lipid cream vehicle (Drug)
结局指标
主要结局
The percentage change in modified Eczema Area and Severity Index (m-EASI) on trunk and extremities at Day 15
时间窗: 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.
次要结局
- 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)
- Investigator's Global Assessment (IGA) at Day 15(at Day 15)
- Controlled disease according to IGA(at Day 15)