Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01670032
Eligibility Criteria:
Inclusion Criteria:
* Male or female 2 years of age or older
* Clinical diagnosis of primary impetigo (bullous or non bullous)
* Minimum diameter of Target Lesion to be one centimeter measured either as length or width.
* Presence of at least one and no more than ten lesions per subject at the time of screening
* The infected lesions' total area (as determined by the Investigator) must be less than 100 cm2 in total area for subjects 18 years of age or older, or up to a maximum of 2% total body surface area for subjects younger than 18 years of age.
* Skin Infection Rating Scale (SIRS) total score of the Target Lesion of at least 4
Exclusion Criteria:
* Presence of other active skin diseases at or near the Target Lesion area to be treated
* A subject whose disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed
* Signs and symptoms of another current infection requiring antibiotic treatment
* Tympanic temperature at Screening/Baseline exceeding 38 degrees Celsius (100.4 degrees Fahrenheit) in a pediatric subject or 37.8 degrees Celsius (100 degrees Fahrenheit) in an adult subject
* History of Hepatitis B or C, HIV/ AIDS, or other immunodeficiency disease
* Concurrent or recent scabies infection or lice infestation (pediculosis) of the scalp
* Use of systemic antibiotics or systemic steroids within 14 days prior to study entry. A history of three or more courses of systemic antibiotics within the 3 month period immediately prior to screening will also be considered exclusionary
* Use of topical antibiotics, topical antibacterials, topical antifungals or topical steroids within 14 days prior to study entry on any skin lesion (as deemed significant by the Investigator by virtue of the lesion's nature and/or position to impact on the effectiveness of the study drug)
* Participation in any other clinical study or use of any investigational drugs or investigational device within 30 days prior to enrollment
* Presence of secondarily infected traumatic lesions (e.g. surgical wounds, animal/insect bites, burns, lacerations and abrasions).
* Another family member in same household currently enrolled in this study or another family member in the same household with active impetigo
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT01670032
Study Brief:
Protocol Section:
NCT01670032