Impetigo
Conditions
Interventions
Product Name: ozenoxacin
Pharmaceutical Form: Cream
INN or Proposed INN: NA
CAS Number: 245765-41-7
Current Sponsor code: GF-001001-00
Other descriptive name: OZENOXACIN
Concentration unit: % percent
Sponsors
Ferrer Internacional, SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent from the patient, legally acceptable representative or parent and able to follow study procedures. 2. Male and female patients ?2 months of age. 3. Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 2-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Has an underlying skin disease, such as pre-existing eczematous dermatitis, with clinical evidence of secondary infection. 2. Has a bacterial infection which, in the opinion of the investigator, could not be appropriately treated by a topical antibiotic. 3. Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F) 4. Documented or suspected bacteraemia. 5. Treatment with the following anti-infective agents prior to study drug administration: oral antibiotic within 7 days; topical antibiotic (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)), within 7 days; a long-acting injectable antibiotic within 30 days. 6. Has applied any topical therapeutic agent (including, but not limited to, glucocorticoid steroids) directly to the impetigo lesions within 24 hours before entry into the study. 7. Has applied any topical (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)) treatment with antiseptics (e.g. alcohol, chlorhexidine, hydrogen peroxide or iodine) or other treatment that in the investigator?s opinion could confound the evaluation of the treatment effect on the investigational area(s) within 8 hours before study start or planned treatment during the study. 8. Has taken any systemic or topical (at the investigational area(s) or within 5 cm from the edge of the investigational area(s)) treatment with analgesics, anti-inflammatory or antihistaminic within 8 hours before entry into the study. 9. 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. 10. Known human immunodeficiency virus (HIV) infection, or evidence of clinically significant immunosuppression. 11. Current medical history of uncontrolled diabetes. 12. Is pregnant or lactating. 13. Known or suspected hypersensitivity to quinolones or any of the excipients in the cream of the investigational product. 14. 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. 15. Have received treatment with any other investigational drug in the last 30 days before study entry. 16. Have previously been enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy of a twice daily topical application for 5 days (10 applications) of an ozenoxacin 1% cream versus placebo in patients with impetigo.;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of a twice daily topical application for 5 days (10 applications) of an ozenoxacin 1% cream in patients with impetigo;Primary end point(s): The primary efficacy endpoint will be: ? Clinical response (success or failure) at end of therapy (Visit 3, Day 6-7) in the intent-to-treat clinical (ITTC) population.;Timepoint(s) of evaluation of this end point: visit 3 Day 6-7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Visits 2, 3, 4;Secondary end point(s): The secondary efficacy endpoints will be: ? Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the per protocol clinical (PPC), per protocol bacteriological (PPB), and intent-to-treat bacteriological (ITTB) populations. ? Clinical response (clinical success or clinical failure) at end of therapy visit (Visit 3) in the ITTC, PPC, PPB, and ITTB populations with a combined criteria of clinical success (including SIRS and size/extension of lesion). According to these criteria clinical success is defined as follows: o Total absence of the treated lesions (lesion extension= 0) OR o the treated lesions have become dry without crusts compared to baseline (SIRS=0 for exudate and for crusting), OR o improvement (defined a decline in the size of the affected area, number of lesions or both) such that no further antimicrobial therapy is necessary. ? Clinical response (early cure, improvement, no improvement) at Visit 2 in the ITTC, PPC, ITTB, and PPB populations. Clinical response (cure, unchange, relapse) at Visit 4 in the ITTC, PPC, ITTB, and PPB population. ? The difference from baseline (Visit 1) in Skin Infection Rating Scale (SIRS) scores at Visit 2, Visit 3 and Visit 4 in the ITTC, PPC, ITTB, and PPB populations. ? The difference from baseline (Visit1) in the size of the affected area at Visit 2, Visit 3 and Visit 4 in the ITTC, PPC, ITTB, and PPB populations. ? Microbiological response (microbiological success or microbiological failure) at Visit 2 and Visit 3 in the ITTB, and PPB population. ? Microbiological response (microbiological recurrence or microbiological reinfection) at Visit 4 in the ITTB, and PPB population. ? Therapeutic response (combined clinical and microbiological response, success or failure) at Visit 3 in the ITTB and PPB populations. ? Time to clinical response ? Time to bacterial eradication ? Clinical and Microbiological re | — |
Countries
Germany, Puerto Rico, Romania, Russian Federation, South Africa, Spain, United States
Contacts
Public ContactClinical Development
Ferrer Internacional, SA
Outcome results
None listed