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Completed

NCT Number: NCT01005771

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

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

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Key information

Conditions

Secondarily Infected Traumatic Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatologische Praxis

Mahlow, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GF-001001-00

Drug

GF-001001-00 2%, 1% and 0.25% twice daily for 7 days

Placebo

Drug

Matching placebo

Primary outcomes

  1. Clinical cure

    Time frame: Day 14

Secondary outcomes

  1. Microbiological cure

    Time frame: Day 14

  2. Adverse events Clinical laboratory parameters Vital signs

    Time frame: Day 14

Sponsors and collaborators

Lead sponsor

Ferrer Internacional S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 2, 2009
Registry last updated
Jun 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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