Secondarily-infected traumatic lesions MedDRA version: 9.1 Level: LLT Classification code 10040872 Term: Skin infection
Conditions
Interventions
Product Name: GF-001001-00
Product Code: GF-001001-00
Pharmaceutical Form: Cream
INN or Proposed INN: Ozenoxacin
CAS Number: 245765-41-7
Current Sponsor code: GF-001001-00
Concentration unit: % (W/W)
Sponsors
Ferrer International, SA
Eligibility
Sex/Gender
All
Inclusion 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. The infected portion of the laceration or sutured wound should be comprised between 2 and 10 cm in length or a total surface area of 2-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of the wound. Abrasions and burns should not exceed a total surface area of 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of the abrasion. • The infection is accompanied by pus/exudate and one or more of the following local signs and symptoms: - Pain - Erythema / Inflammation - Tissue warmth - Tissue oedema - Crusting - Itching • Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 2. • An accessible infection site for culture. • Females of childbearing potential must use a reliable method of contraception (i.e. barrier type devices [e.g. female condom, diaphragm, contraceptive sponge] only in combination with a spermicide; intra-uterine devices; oral, injectable, transdermal or implantable contraceptives only in combination with a barrier method). Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least one year prior to screening), or surgically sterile (tubal ligation and/or hysterectomy). • Willing and able to give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic (e.g. cellulitis, abscess, ulcer). • A complicated skin and skin structure infection as judged by the investigator. • Treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; a long-acting injectable antibiotic within 30 days. • Application of any topical therapeutic agent (including glucocorticoid steroids, antibacterials or antifungals) directly to the infected wound/lesion within 24 hours prior to study entry. • Any infection which requires the use of a concomitant antimicrobial agent in addition to study drug. • A chronic or underlying skin condition at the site of infection (e.g. a secondary infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g. catheter tunnel infections, orthopaedic hardware). • A wound secondary to animal or human bite • Any infection site that requires intraoperative surgical debridement or excision of the infected area. • Documented or suspected bacteraemia. • Daily dose of >15 mg of systemic prednisone or equivalent for >10 days within the period starting 14 days prior to study drug administration or anticipated through the study period. • Known human immunodeficiency virus (HIV) infection, or evidence of clinically significant immunosuppression. • Pregnancy or lactation • Hypersensitivity to quinolones. • Receipt of an investigational agent =3 months prior to the baseline evaluation. • Underlying condition and/or disease that, according to the judgment of the Investigator, would be likely to interfere with completion of the course of study drug therapy or follow-up. • Previous enrolment in this protocol. • Known or suspected hypersensitivity to the investigational product or any of the excipients in the cream.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the safety and tolerability of 3 different doses of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions;Main Objective: To determine the most effective dose of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions;Primary end point(s): Primary efficacy endpoint: • Clinical response (success or failure) at the Final Visit (Day 14) in the ITTC population. Safety endpoints: • Adverse events. • Clinical laboratory parameters (haematology, clinical chemistry, urinalysis). • Vital signs (oral temperature, respiratory rate, pulse rate, BP). • Physical examination. • Exposure to treatment and treatment compliance. | — |
Countries
Czech Republic, France, Germany, Italy, Spain
Outcome results
None listed