Impetigo MedDRA version: 14.1 Level: PT Classification code 10021531 Term: Impetigo System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Ozenoxacin
Product Code: GF-001001-00
Pharmaceutical Form: Cream
INN or Proposed INN: Ozenoxacin
CAS Number: 245765-41-7
Current Sponsor code: Ozenoxacin
Other descriptive name: GF-00100
Sponsors
Ferrer Internacional, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria will be considered eligible to participate in the clinical study: 1. Written informed consent. 2. Males and females, 2 months to 65 years. 3.Patients with a clinical diagnosis of non-bullous or bullous impetigo. 4.The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. 5.Females of childbearing potential: negative urine pregnancy test. 6.Females: surgically sterile for at least 6 months prior to first application of the IMP; pre-menarchial or postmenopausal women who are amenorrhoeic for at least 12 months; or if of childbearing potential, must in the opinion of the investigator, be using a suitable and effective contraceptive method during the study. Females must agree not to become pregnant during the period of IMP exposure. 7.Treatment with the following agents prior to study drug administration (when applicable): -At least one week since last systemic oral antibiotic therapy or last topical antibiotic therapy. -At least 30 days since last long-acting injectable antibiotic. -At least 24 h since last topical therapeutic agent. -At least 8 h since last topical antiseptic or other treatment that in the investigator’s opinion could confound the evaluation of the treatment effect on the investigational area(s) applied directly to the impetigo lesions -At least 8 h since last administration of any systemic or topical anti-inflammatory, antihistamine or analgesic drug. Are the trial subjects under 18? yes Number of subjects for this age range: 42 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet one or more of the following criteria will not be considered eligible to participate in the clinical study: 1. A history of hypersensitivity to the IMP or any of the excipients or to medicinal products with similar chemical structures. 2. Treatment with any other IMP in the last 12 weeks before administration of the first dose in this clinical study. 3. Pregnant or lactating women. 4. Received systemic or topical skin treatment with immunosuppressive agents within 21 days before dosing with the IMP. 5. Current medical history of uncontrolled diabetes. 6. A history of, or known current problems with, drug or alcohol abuse. 7. Vulnerable patients (e.g., persons kept in detention). 8. Any concurrent disease, condition or therapy that in the opinion of the Investigator would make the patient unsuitable for participation in the clinical study. 9. Planned treatment with antibacterial medication (other than the IMP) during the study. 10. Signs and symptoms of systemic infection. 11. Presence of skin infection not amenable to topical treatment only. 12. Have a history of or are currently being treated for active AIDS, hepatitis B or hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the systemic absorption of ozenoxacin 1% cream following repeated topical applications by analysing plasma ozenoxacin concentrations in patients with impetigo.;Secondary Objective: To assess the safety and tolerability of ozenoxacin 1% cream after repeated topical applications in patients with impetigo. Clinical response at the end of therapy will also be evaluated. ;Primary end point(s): The systemic absorption following repeated topical applications of ozenoxacin 1% cream will be assessed, by analysing the plasma ozenoxacin concentrations.;Timepoint(s) of evaluation of this end point: Ozenoxacin plasma concentrations will be assessed at visit 1 (Day 1), visit 2 (Day 2), visit 3 (Day 4) and visit 4 (Day 6) in all age subsets and additionally and only for paediatric subset aged 12 years to less than 18 years and adults, at visit 5 (Day 7). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: - Adverse events - Safety laboratory data - Vital signs - Physical exam - Treatment compliance Efficacy: - Clinical response;Timepoint(s) of evaluation of this end point: Safety: - Adverse events, vital signs and physical exam: at visit 1 (Day), visit 2 (Day 2), visit 3 (Day 4) and visit 4 (Day 6) in all age subsets and additionally and only for paediatric subset aged 12 years to less than 18 years and adults, at visit 5 (Day 7). - Safety laboratory data: visit 1 (Day 1) for all age subsets and visit 4 (Day 6) for age subsets > 6 months only. - Treatment compliance: at visit 4 (Day 6). Efficacy: - Clinical response: at visit 4 (Day 6). | — |
Countries
South Africa
Contacts
Public ContactClinical Trial Information
Ferrer Internacional, S.A.
Outcome results
None listed