Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions

Phase 2

Completed

• Conditions: Secondarily Infected Traumatic Lesions
• Interventions: Drug: GF-001001-00; Drug: Placebo

• Registration Number: NCT01005771
• Lead Sponsor: Ferrer Internacional S.A.

Brief Summary

This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.

Detailed Description

200 eligible patients will be included in the double-blind phase (50 in each group, randomised 1:1:1:1 to GF-001001-00 at a concentration of 0.25%, 1% or 2% or placebo).

Randomised patients will apply the study medication as follows depending on their assigned treatment group.

* GF-001001-00 2%, 2 times daily, for 7 days

* GF-001001-00 1%, 2 times daily, for 7 days

* GF-001001-00 0.25%, 2 times daily, for 7 days

* Placebo, 2 times daily, for 7 days

The first application will be done after randomisation at Visit 1 under the guidance of the investigator. Patients will return for control visits: Visit 2 (Day 5) and Visit 3 (Day 7), after randomisation. Patients will return for the Final Visit (Visit 4, Day 14 after initiation of treatment).

Primary objective:

To determine the most effective dose of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions.

Primary efficacy endpoint:

Clinical response (success or failure) at the Final Visit (Day 14) in the ITTC population.

Study Timeline

• Study First Submitted: 2009-08-04
• Study Start: 2009-09
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-08
• Last Update Posted: 2010-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Males and females ≥ 18 years of age.
• Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.

Exclusion Criteria

• None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GF-001001-00 2%	GF-001001-00	-
GF-001001-00 1%	GF-001001-00	-
Placebo	Placebo	-
GF-001001-00 0.25%	GF-001001-00	-

Primary Outcome Measures

Name	Time	Method
Clinical cure	Day 14

Secondary Outcome Measures

Name	Time	Method
Microbiological cure	Day 14
Adverse events Clinical laboratory parameters Vital signs	Day 14

Trial Locations

Locations (1)

Dermatologische Praxis; 🇩🇪 Mahlow, Germany