Phase III, Random, Blind to Observer, Multicenter, Comparative Study, to Demonstrate Absence of Inferiority in Safety and Efficacy of Topical Ointment SB-275833 at 1% Applied Twice a Day for Five Days, Against Topical Ointment of 2% Sodium Fusidate Applied Three Times a Day for 7 Days in the Treatment of Adult and Pediatric Subjects with Impetigo

Not Applicable

• Conditions: -L01; L01

• Registration Number: PER-012-05
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. The patient is> 9 months of age.
2. The patient has a clinical diagnosis of primary impetigo
3. The patient has no 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 his informed consent
FOR CHILDREN UNDER 18 YEARS OF AGE
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.
11. The parent / legal guardian has given informed consent

Exclusion Criteria

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, due to its depth or severity, 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, which could be immediately potentially lethal.
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