Non-Inferiority Trial of Topical Mupirocin Gel Versus Ointment in Pediatric Impetigo Treatment

The primary objective of this clinical trial is to assess the therapeutic **non-inferiority** of twice-daily (BID) topical administration of Impetine® Gel (mupirocin 20 mg/g) compared to thrice-daily (TID) administration of Bactroban® Ointment (mupirocin 20 mg/g) in the treatment of **impetigo**. This evaluation focuses on achieving clinical cure based on the Skin Infection Rating Scale (SIRS) at the end of follow-up (EOF), which is clinically relevant as it aims to optimize dosing frequency while maintaining efficacy.

Secondary objectives include:

• Comparing the clinical cure at the end of treatment (EOT) based on SIRS, total SIRS scores at EOT and EOF, and bacteriological cure at EOF between the two treatment regimens.
• Assessing patient satisfaction with the treatments through a satisfaction questionnaire.
• Evaluating the safety of the BID administration of Impetine® Gel.

The clinical trial involves a study population of both **male** and **female** participants aged between 18 months and 15 years, diagnosed with either bullous or non-bullous **impetigo**. Participants are required to be in good health, confirmed by medical history and physical examination, and free from any clinically significant conditions other than impetigo that could interfere with study evaluations. The trial includes individuals whose skin pigmentation allows for accurate clinical evaluation using the Skin Infection Rating Scale (SIRS). Participants must have a suspected positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the target site. The trial population is selected based on the ability of participants and/or their parents/guardians to understand and comply with the trial requirements, with informed consent signed by a parent or legal guardian, and informed assent by mature minors aged 12 or older. The sponsor has not provided information regarding the total number of participants. Key lifestyle considerations include the requirement for participants of childbearing potential to have a negative urine pregnancy test at baseline and to agree to use adequate contraception if applicable. The trial involves a vulnerable population, as it includes minors.

The clinical trial is a **multicenter**, randomized, open-label study with blind evaluation, designed to assess the non-inferiority of Impetine® Gel (mupirocin 20 mg/g) compared to Bactroban® Ointment (mupirocin 20 mg/g) in the treatment of **impetigo** in a pediatric population. The trial aims to evaluate the efficacy and safety of these topical applications, with a focus on dose optimization. The study is classified as low interventional, as the investigational medicinal products (IMPs) are used in accordance with their marketing authorizations, and the additional diagnostic and monitoring procedures are minimal in risk and burden.

The trial will involve a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as a clinical diagnosis of bullous or non-bullous impetigo, good health status, and a suspected positive baseline culture for **Staphylococcus aureus** and/or **Streptococcus pyogenes**. Participants will be aged between 18 months and 15 years. The trial will proceed with follow-up visits to monitor the clinical cure based on the Skin Infection Rating Scale (SIRS) and to assess any adverse events. The primary endpoint is the clinical cure at the end of follow-up (EOF), measured at Visit 4, while secondary endpoints include clinical cure at the end of treatment (EOT) and EOF, total SIRS scores, bacteriological cure, treatment satisfaction, and incidence of adverse events.

The overall trial duration is estimated to conclude by August 2026, with recruitment starting in June 2025. Participant involvement is expected to last for a maximum treatment period of 7 days, with the possibility of early termination if any exclusion criteria are met or if adverse events occur that warrant withdrawal from the study. The trial is designed to ensure that participants and their guardians understand and comply with the trial requirements, including the use of adequate contraception for participants of childbearing potential. The study will be conducted in accordance with ethical standards, with informed consent obtained from parents or legal guardians and assent from mature minors.

The clinical trial involves the evaluation of two topical formulations containing **mupirocin** for the treatment of impetigo in the pediatric population. The experimental medication, Impetine® 20mg/g Gel, is a topical **gel** formulation containing mupirocin as the active ingredient. It is manufactured by Laboratorios Ojer Pharma, S.L. The gel is applied topically twice daily (BID) for a maximum treatment period of 7 days. The maximum daily dose is 2 applications per day, with a total maximum dose of 14 applications over the treatment period. The administration route is topical, and participant compliance is monitored through scheduled visits and assessments.

The comparator treatment in this study is Bactroban® 20 mg/g Ointment, which also contains mupirocin as the active substance. This ointment is produced by GlaxoSmithKline, S.A. and is applied topically three times daily (TID) for up to 7 days. The maximum daily dose is 3 applications per day, with a total maximum dose of 21 applications throughout the treatment duration. Similar to the experimental treatment, the administration route is topical, and compliance is monitored through clinical evaluations and follow-up visits. Both treatments are classified as antibiotics and are not pediatric formulations. The trial aims to assess the non-inferiority of Impetine® Gel compared to Bactroban® Ointment in achieving clinical cure based on the Skin Infection Rating Scale (SIRS) at the end of the follow-up period.

The efficacy of the clinical trial will be assessed by evaluating the therapeutic non-inferiority of Impetine® Gel (mupirocin 20 mg/g) compared to Bactroban® Ointment (mupirocin 20 mg/g) in the treatment of **impetigo**. The primary endpoint for efficacy is the clinical cure at the end of follow-up (EOF), specifically at Visit 4, as measured by the proportion of subjects achieving clinical cure based on the Skin Infection Rating Scale (SIRS) according to a blinded assessor. Secondary endpoints include clinical cure at the end of treatment (EOT) at Visit 3, total SIRS scores at both EOT and EOF, bacteriological cure at EOF, treatment satisfaction at EOT, and the incidence of adverse events.

The SIRS will be utilized as a validated tool to measure clinical outcomes, with assessments conducted by both a blinded assessor and the investigator. The schedule for efficacy assessments includes key timepoints at EOT and EOF, ensuring comprehensive evaluation of the treatment's impact. The trial is designed as a multicenter, randomized, open-label study with blind evaluation, ensuring robust and unbiased assessment of the efficacy parameters.