“A Phase III, Prospective, Randomized, Double Blind, Single Dummy, Active Controlled, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Ozenoxacin Cream 1% w/w Versus Mupirocin Cream 2% w/w in the treatment of Patients with Impetigo.â€
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Clinical response at the end of the study (Visit 4).
研究概览
简要总结
Thisis a phase III, prospective, randomized,double blind, single dummy, active controlled, comparative, parallel group,multicenter clinical study to evaluate the efficacy and safety of OzenoxacinCream 1% w/w versus Mupirocin Cream 2% w/w in the treatment of patients withimpetigo.
After confirmingthe inclusion/exclusion criteria the patient will be randomized and providedwith study medication at screening/baseline/randomization visit (Visit 1). Patientswill be provided with diary at screening/baseline/randomization visit (Visit 1),which needs to be brought along with in each subsequent visit till the lastvisit (Visit 4). Follow up visits will be done on Day 3-4 (Visit 2), Day 6-7(Visit 3) and Day 11-12 (Visit 4/End of the study) of treatment to assess efficacyand safety.
Patientswho are willing and able to participate in the study will sign and date theInformed Consent Form on the day of screening / baseline / randomization visit(Visit 1). During this screening period, patients who are willing to giveconsent will be evaluated for all the eligibility criteria. Eligible patientsaged at least 2 years fulfilling all inclusion criteria and none of theexclusion criteria will be considered for the study.
Patientswill be assigned to either of the two arms i.e. Arm A or Arm B consisting of OzenoxacinCream 1% w/w or Mupirocin Cream 2% w/w. Patients will be given the studymedication for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients at least 2 years of age.
- •Patients with clinical diagnosis of bullous or non-bullous impetigo.
- •The patient was required to have a total affected area comprised between 1 to 100 cm2 with surrounding erythema not exceeding more than 2 cm from the edge of any affected area.
- •In case of multiple affected areas, the total area was sum of each affected area and was not to exceed 100 cm
- •Additionally, for patients less than 12 years, the total area was not to exceed a maximum of 2% of the body surface area.
- •Patients with total skin infection rating scale (SIRS) score of at least 3, including pus/exudate score of at least
- •Written informed consent from the patient, legally acceptable representative or parent and able to follow study procedures.
排除标准
- •Patients with known or suspected hypersensitivity to quinolones or Mupirocin.
- •Female Patients who are pregnant or lactating or planning to become pregnant during the study period.
- •Females of child bearing potential who are not ready to use acceptable contraceptive methods during the course of study.
- •Patients who have an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection.
- •Patients who have a bacterial infection which, in the opinion of investigator, could not be appropriately treated by a topical antibiotic.
- •Patients who have systemic signs and symptoms of infection (e.g., a fever; defined as an axillary temperature over 37.2 oC (99.0 oF).
- •Patients with documented or suspected bacteraemia.
- •Treatment with the following anti-infective agents prior to study drug administration: oral antibiotic within 7 days; topical antibiotic (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)), within 7 days; a long-acting injectable antibiotic within 30 days.
- •Patients who have applied any topical therapeutic agent (including, but not limited to, glucocorticoid steroids) directly to the impetigo lesions within 24 hours before entry into the study.
- •Patients who have applied any topical (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)) treatment with antiseptics (e.g., Alcohol, Chlorhexidine, Hydrogen peroxide or Iodine) or other treatment that in the investigator’s opinion could confound the evaluation of the treatment effect on the investigational area(s) within 8 hours before study start or planned treatment during the study.
- •Patients who have taken any systemic or topical (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)) treatment with analgesics, anti-inflammatory or antihistaminic within 8 hours before entry into the study.
- •Patients who are taking daily dose of >15 mg of systemic prednisone or equivalent for >10 days within the period starting 14 days prior to study drug administration or anticipated through the study period.
- •Patients with known human immunodeficiency virus (HIV) infection or evidence of clinically significant immunosuppression.
- •Patients with known history of type 1 and type 2 diabetes mellitus.
- •Patients who have participated in any clinical trial in the past 3 months.
- •Patients with underlying condition and/or disease that, according to the judgment of the Investigator, would likely to interfere with completion of the course of the study drug therapy or follow-up.
结局指标
主要结局
Clinical response at the end of the study (Visit 4).
时间窗: Day 11-12
次要结局
- Clinical response at Visit 2 and Visit 3.(Day 3-4 and Day 6-7)
- The difference from baseline (Visit 1) in SIRS scores at Visit 2, Visit 3 and Visit 4.(Day 1, Day 3-4, Day 6-7 and Day 11-12)
- Size of the affected area at Visit 2, Visit 3 and Visit 4 as compared to baseline (Visit 1).(Day 1, Day 3-4, Day 6-7 and Day 11-12)
- Microbiological response (microbiological success or microbiological failure) at Visit 2, Visit 3 and Visit 4.(Day 3-4, Day 6-7 and Day 11-12)