A Clinical Study to Compare the Efficacy and Safety of Ozenoxacin Cream 1% w/w in patients with Secondarily Infected Traumatic Skin Lesions
- Conditions
- Health Condition 1: L010- Impetigo
- Registration Number
- CTRI/2020/12/029449
- Lead Sponsor
- Om Sai Pharma Pack
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 204
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response at the end of the study (Visit 4).Timepoint: Day 11-12
- Secondary Outcome Measures
Name Time Method Clinical response at Visit 2 and Visit 3.Timepoint: Day 3-4 and Day 6-7;Microbiological response (microbiological success or microbiological failure) at Visit 2, Visit 3 and Visit 4.Timepoint: 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).Timepoint: Day 1, Day 3-4, Day 6-7 and Day 11-12;The difference from baseline (Visit 1) in SIRS scores at Visit 2, Visit 3 and Visit 4.Timepoint: Day 1, Day 3-4, Day 6-7 and Day 11-12