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

June 8, 2010 updated by: Ferrer Internacional S.A.

GF-001001-00 Cream.A Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of 3 Different Doses of GF-001001-00 Cream Versus Placebo Cream Applied 2 Times Daily for 7 Days in the Treatment of Adult Patients With Secondarily-infected Traumatic Lesions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mahlow, Germany
        • Dermatologische Praxis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GF-001001-00 2%
Drug: GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
Experimental: GF-001001-00 1%
Drug: GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
Experimental: GF-001001-00 0.25%
Drug: GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical cure
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Microbiological cure
Time Frame: Day 14
Day 14
Adverse events Clinical laboratory parameters Vital signs
Time Frame: Day 14
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferrer Internacional S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2010

Last Update Submitted That Met QC Criteria

June 8, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P-080623-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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