Study to evaluate the efficacy and safety of an antibiotic cream admistered twice daily for 5 days in patients, including children, with an skin infection called impetigo

• Conditions: Impetigo; MedDRA version: 14.1Level: PTClassification code 10021531Term: ImpetigoSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-003032-31-DE
• Lead Sponsor: Ferrer Internacional, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-23
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

Patients will be entered into this study only if they meet all of the following 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 years of age.
3. Clinical diagnosis of bullous or non bullous impetigo. 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. 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 < 12 years the total area will not exceed a maximum of 2% of the body surface area.
4. Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1
5. 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). Females are not of childbearing potential if they are pre-menarchical, postmenopausal (i.e. amenorrhea for at least 1 year prior to screening), or surgically sterile (tubal ligation and/or hysterectomy).

Are the trial subjects under 18? yes
Number of subjects for this age range: 282
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

Patients that meet any of the following criteria must not be enrolled in the study:
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. Known or suspected hypersensitivity to retapamulin or any of the excipients in the ointment of the investigational product.
15. 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.
16. Have received treatment with any other investigational drug in the last 30 days before study entry.
17. Have previously been enrolled in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified