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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005771
First Posted: November 2, 2009
Last Update Posted: June 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ferrer Internacional S.A.
  Purpose
This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.

Condition Intervention Phase
Secondarily Infected Traumatic Lesions Drug: GF-001001-00 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:
  • Clinical cure [ Time Frame: Day 14 ]

Secondary Outcome Measures:
  • Microbiological cure [ Time Frame: Day 14 ]
  • Adverse events Clinical laboratory parameters Vital signs [ Time Frame: Day 14 ]

Enrollment: 200
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005771


Locations
Germany
Dermatologische Praxis
Mahlow, Germany
Sponsors and Collaborators
Ferrer Internacional S.A.
  More Information

Responsible Party: Nuria Albareda, Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01005771     History of Changes
Other Study ID Numbers: P-080623-01
First Submitted: August 4, 2009
First Posted: November 2, 2009
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by Ferrer Internacional S.A.:
Secondarily infected traumatic lesions