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

This study has been completed.
Sponsor:
Information provided by:
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01005771
First received: August 4, 2009
Last updated: June 8, 2010
Last verified: June 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005771

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

No publications provided

Responsible Party: Nuria Albareda, Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01005771     History of Changes
Other Study ID Numbers: P-080623-01
Study First Received: August 4, 2009
Last Updated: June 8, 2010
Health Authority: Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014