Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment

A Randomised, Double-blind, Multicentre, Superiority Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of Topical 1% SB-275833 Ointment Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adults and Paediatric Subjects With Impetigo.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00133848

Enrollment

210

Registered

2005-08-24

Start date

2005-04-30

Completion date

2006-01-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impetigo

Keywords

impetigo, topical antibacterial, topical antibiotic

Brief summary

The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective than a placebo ointment in the treatment of primary impetigo.

Interventions

DRUGSB-275833 ointment, 1%

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

9 Months to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.	—

Secondary

Measure	Time frame
Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.	—

Countries

India, Italy, Mexico, Netherlands, Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026