CTRI/2020/12/029449已完成3 期
â??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
- 204
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female patients at least 2 years of age.
- •2. 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 cm2. Additionally, for patients less than 12 years, the total area was not to exceed a maximum of 2% of the body surface area.
- •3. Patients with total skin infection rating scale (SIRS) score of at least 3, including pus/exudate score of at least 1.
- •4. Written informed consent from the patient, legally acceptable representative or parent and able to follow study procedures.
排除标准
- •1. Patients with known or suspected hypersensitivity to quinolones or Mupirocin.
- •2. Female Patients who are pregnant or lactating or planning to become pregnant during the study period.
- •3. Females of child bearing potential who are not ready to use acceptable contraceptive methods during the course of study.
- •4. Patients who have an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection.
- •5. Patients who have a bacterial infection which, in the opinion of investigator, could not be appropriately treated by a topical antibiotic.
- •6. 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).
- •7. Patients with documented or suspected bacteraemia.
- •8. 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.
- •9. 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.
- •10. 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 investigatorâ??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.
- •11. 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.
- •12. 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.
- •13. Patients with known human immunodeficiency virus (HIV) infection or evidence of clinically significant immunosuppression.
- •14. Patients with known history of type 1 and type 2 diabetes mellitus.
- •15. Patients who have participated in any clinical trial in the past 3 months.
- •16. 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.
研究者
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