A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Demonstrate Superiority and Phase III, in order to Assess the Efficacy and Safety of SB-275833 in 1% Topical Ointment versus Placebo in Ointment Applied Twice by Day for 5 Days in the Treatment of Adult and Pediatric Subjects with Impetigo
- Conditions
- -L01L01
- Registration Number
- PER-013-05
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. The patient is > 9 months of age.
2. The patient has a clinical diagnosis of primary impetigo.
3. The patient does not have more than 10 lesions.
4. The infected lesion (s) must not exceed 100 cm in area.
5. Female patients with potential to have family who have had a negative result in a urine test to diagnose pregnancy.
6. The patient has a score on the Skin Infection Rating Scale in at least 8.
7. The patient is willing and able to comply with the study protocol.
8. The patient has given written and dated informed consent to participate in the study.
For pediatric patients below the legal age for consent:
9. The parent / legal guardian is willing to comply with the protocol.
10. The child has given his / her assent to participate in the study.
1. The patient has demonstrated a prior hypersensitivity reaction to pleuromutilin or any component of the ointment.
2. The patient has an underlying skin disease.
3. The patient has signs and symptoms of a systemic infection.
4. The patient has a bacterial infection of the skin; which, can not be treated properly with a topical antibiotic.
5. The patient has received an antibacterial or a systemic steroid, or a topical therapeutic agent has been applied less than 24 hours before entering the study.
6. The patient has a serious underlying disease.
7. The patient is pregnant, breastfeeding or planning to become pregnant during the study.
8. The patient has used a drug under investigation during the 30 days prior to entering the study.
9. The patient has been previously enrolled in the present study or in any other study involving SB-275833.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation<br>Measure:Eficacia del SB-275833 en ungüento al 1%<br>Timepoints:7th day of the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:1) Clinical Final Events: Clinical Evaluation<br>2) Microbiological Final Events: Injury cultures<br>Measure:1) Clinical Final Events: Clinical response in the follow-up. Evaluation of the area of the lesions at the end of the therapy.<br>2) Microbiological Final Events: Microbiological response at the end of the treatment. Microbiological response during follow-up. Number and percentage of patients in whom methicillin-resistant Staphylococcus aureus was isolated at the beginning, end of treatment and during follow-up<br>Timepoints:1) Clinical Final Events: Days 7 and 14<br>2) Microbiological end events: Microbiological response on Day 7. Microbiological response on Day 14. Number and percentage of patients in whom methicillin-resistant Staphylococcus aureus was isolated. (Day1), at the end of therapy on Day 7, after treatment and on Day 14 at follow-up<br>