Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Skin Infections, Bacterial

Treatments: Drug: SB-275833 ointment, 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00133874

TOC100224

Details and patient eligibility

About

The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.

Full description

A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.

Enrollment: 520 patients

Sex: All

Ages: 9+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have primary impetigo with total lesion area being 100 square centimeters or less.
• Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures.

Exclusion criteria

• Any signs and symptoms of systemic infection.
• Any serious underlying disease that could be imminently life threatening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind