XEPI is a drug for treatment of impetigo due to certain bacteria (Staphylococcus aureus or Streptococcus pyogenes) in patients 2 months of age and older. Impetigo is a contagious bacterial skin infection that occurs primarily in children.
XEPI is a cream. It is applied two times a day for 5 days in a thin layer to the areas of skin where impetigo is present.
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to XEPI Prescribing Information for complete information.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
Sex: XEPI worked similarly in male and female patients.
Race: XEPI worked similarly in Black or African American and in White patients. The number of patients in other races was limited; therefore, differences in response among all races could not be determined.
Age: XEPI worked better in patients younger than 12 years of age than in older ones.
The FDA approved XEPI based on evidence from two clinical trials (NCT 01397461 and NCT 02090764) of 723 patients with impetigo. The trials were conducted in the USA, Europe, South Africa and Puerto Rico.
The figure below summarizes how many males and females were in the clinical trials.
Figure 1. Baseline Demographics by Sex
FDA Statistical review
Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trials.
Figure 2. Baseline Demographics by Race
FDA Statistical review
Table 1. Baseline Demographics by Race
Number of Patients
Black or African American
American Indian or Alaska Native
less than 1
Figure 3 summarizes the percentage of patients by age in the clinical trials.
The benefit and side effects of XEPI were evaluated in two clinical trials of patients with impetigo. In both trials patients received treatment with either XEPI or placebo cream twice daily for 5 days. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.
At the end of therapy, patients were evaluated for improvement of clinical signs and symptoms of impetigo and need for additional antibacterial treatment.
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested. EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial. PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo. SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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