Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 773
- 试验地点
- 2
- 主要终点
- Participants With Clinical Cure According to Investigator's Assessment
研究概览
简要总结
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.
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)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent from patient and/or legally acceptable representative has been obtained
- •Outpatients of any sex or ethnic origin
- •Patients >= 2 years of age (depending on study step)
- •Patients must be suffering from primary bullous/non-bullous impetigo or SITL
排除标准
- •Presence of skin diseases at or near the investigational area
- •Immunosuppressed state or other serious systemic disease
- •Signs and/or symptoms of systemic infection
- •Presence of skin infection/disorder not amenable to topical antibacterial treatment only
- •Presence of secondarily-infected animal/human bite
- •Presence of secondarily infected burnwound
- •Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs
- •Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream
- •Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream
- •Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation
- •Patients previously enrolled/randomised in this study
- •Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms
研究组 & 干预措施
1
干预措施: TD1414 2% cream (Drug)
2
干预措施: TD1414 2% cream (Drug)
3
干预措施: Bactroban® (mupirocin) 2% cream (Drug)
结局指标
主要结局
Participants With Clinical Cure According to Investigator's Assessment
时间窗: At end of treatment (Day 8)
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator. Investigator's assessment of severity of infections (SIRS). * Exudates/pus * Crusting * Erythema * Oedema * Tissue Warmth * Itching * Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: * 0 = absent * 2 = mild * 4 = moderate * 6 = severe The scores were summed up to a total SIRS score. Clinical cure was either of the following: * Total absence of signs and symptoms of impetigo/SITL OR * Improvement - total SIRS score reduced to \<8 and all individual clinical signs/symptoms included in the SIRS score should have been ≤4. Clinical failure was either of the following: * Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure * Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
次要结局
- Participants With Clinical Cure According to Investigator's Assessment(At Day 4)
- Participants With Clinical Cure According to Investigator's Assessment.(At end of treatment (Day 8) and follow-up (Day 15))
- Participants With Bacteriological Cure According to Bacteriological Samples(At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up)
- Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples(At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up)