A Randomized, Double-blind, Double-Dummy, Multicenter, Non-inferiority Phase III Study to Assess the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily, versus Oral Cephalexin, 500mg in Adults, or 12.5mg/kg (250mg/5mL) in Children, Twice Daily, in the Treatment of Secondarily-Infected Dermatoses

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000784-97-IT

Enrollment

495

Registered

2005-05-18

Start date

2004-09-15

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Treatment of Secondarily-Infected Dermatoses. MedDRA version: 6.1 Level: HLGT Classification code 10040792

Interventions

Product Name: Pleuromutilin Product Code: SB 275833 Pharmaceutical Form: Ointment Current Sponsor code: SB 275833 Concentration unit: mg milligram(s) Concentration type: equal Pharmaceutical Form: Ca

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026