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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT01803035
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 2 years of age.
* Signed written informed consent document by patient, parent, legal guardian or caretaker.
* Positive Gram-stain of target lesion showing Gram-positive cocci.
* Clinical diagnosis of primary non-bullous impetigo as per protocol.
* Candidate for treatment with topical antibacterial and have a Skin Infection Rating Scale (SIRS) of ≥ 4 with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus.
* Total lesion area ≤ 20 cm2. Single lesion not to exceed 2 cm2.
* No known medical conditions that in the investigators opinion may interfere with study participation or put the patient at additional risk.
Exclusion Criteria:
* Unwillingness or inability of patient, parent, legal guardian or caretaker to comply with the requirements of the protocol.
* Presence of other skin disease at or near the investigational target area to be treated.
* The disease is so widespread or severe that, in the opinion of the investigator, the patient needs oral antibiotic treatment.
* History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease.
* Concurrent or recent scabies infection.
* Signs and symptoms of a current infection requiring antibiotic treatment.
* Tympanic temperature at Baseline \> 38 °C (100.4 °F) in a pediatric patient or 37.8 °C (100 °F) in an adult patient.
* Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry.
* Participation in any other clinical study or use of any other investigational drugs or investigational device within 30 days prior to treatment.
* Known allergy to any constituent of the study medication.
* Presence of secondarily-infected animal/human/insect bite or infected burn wound.
* Other reason which based on the discretion of the investigator makes the patient unsuitable for enrolment.
* Lactating or pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT01803035
Study Brief:
Protocol Section:
NCT01803035