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Comparing two forms of mupirocin (gel and ointment) for treating impetigo in children: a study of different dosing schedules

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating impetigo, which is a common bacterial skin infection that primarily affects children. The study compares two different forms of the same medication containing mupirocin - Impetine® Gel and Bactroban® Ointment - both applied directly to the skin to treat the infection.

The purpose of this research is to determine if using Impetine® Gel twice per day works as effectively as Bactroban® Ointment used three times per day in treating impetigo in children. Both medications contain the same amount of the active ingredient (20 mg/g of mupirocin), but they come in different forms - one as a gel and the other as an ointment.

The treatment period lasts for 7 days, during which participants will apply their assigned medication to the affected skin areas. The study will monitor how well the skin infection heals and check for any side effects. Doctors will examine the treated areas and evaluate the healing process using a special scoring system that looks at various signs of infection.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and examination

    A healthcare professional will examine the impetigo (skin infection) and take a sample from the affected area to confirm the presence of bacteria

    The skin condition will be evaluated using a special scale called Skin Infection Rating Scale (SIRS)

    For female patients of childbearing age, a urine pregnancy test will be performed

  2. Step 2

    Treatment assignment

    You will receive one of two treatments:

    Either Impetine® Gel (mupirocin 20 mg/g) to be applied twice daily

    Or Bactroban® Ointment (mupirocin 20 mg/g) to be applied three times daily

    Both medications are applied directly to the skin

  3. Step 3

    Treatment period and end of treatment visit

    You will apply the assigned medication as directed

    At the end of treatment visit (EOT), a healthcare professional will examine your skin

    The SIRS evaluation will be performed to assess your progress

    You will be asked about your satisfaction with the treatment

    Any side effects will be recorded

  4. Step 4

    Final follow-up visit

    At the end of follow-up visit (EOF), your skin will be examined one final time

    The SIRS evaluation will be performed to determine if the infection is cured

    A sample from the affected area may be taken to check if the bacteria are gone

    Any final side effects will be recorded

Who can join the trial?

11 criteria

  • Must have a clinical diagnosis of bullous or non-bullous impetigo (a bacterial skin infection)
  • Must be in good overall health, without any significant medical conditions other than impetigo that could affect study evaluations
  • The impetigo condition must be suitable for treatment with a topical antibiotic alone (medicine applied to the skin)
  • Must be between 18 months and 15 years old when joining the study
  • Must have a positive test result for specific bacteria (Staphylococcus aureus and/or Streptococcus pyogenes) from the infected skin area
  • Must have a minimum score of 4 on the Skin Infection Rating Scale (SIRS) with at least 3 different signs or symptoms present
  • Skin type must allow proper evaluation of infection symptoms
  • Must have parent or legal guardian consent, and children 12 years or older must also provide their own agreement
  • Participant and parents/guardians must be able to understand and follow study requirements
  • For participants who can become pregnant:
    • Must have a negative pregnancy test at the start of the study
    • Must agree to use appropriate birth control if sexually active

Who cannot join the trial?

12 criteria

  • History of allergic reactions to mupirocin (the active ingredient in study medications) or similar antibiotics
  • Currently taking other antibiotics (oral or topical) for skin infections
  • Severe or extensive skin infections requiring oral or intravenous antibiotics
  • Skin conditions that could interfere with evaluating the treatment response, such as eczema (inflamed, itchy skin) or psoriasis (scaly patches on skin)
  • Weakened immune system due to medical conditions or medications
  • Pregnancy or breastfeeding
  • Active skin cancer or history of skin cancer in the affected areas
  • Treatment with any investigational drug within 30 days before study entry
  • Inability to follow study procedures or attend follow-up visits
  • Known kidney or liver problems that could affect drug metabolism
  • Current participation in other clinical trials
  • History of poor compliance with medical treatments
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Investigated drugs

Impetine® Gel (mupirocin) is a topical antibiotic medication in gel form that is applied directly to the skin to treat impetigo, which is a bacterial skin infection. The gel formulation is designed to be easy to apply and is being tested with twice-daily application. Bactroban® (mupirocin) is a topical antibiotic ointment that is also used to treat impetigo. It is the established treatment option and is typically applied three times per day. The ointment formulation has been widely used as a standard treatment for bacterial skin infections. Both medications contain the same active ingredient (mupirocin) but come in different forms (gel versus ointment) and are being tested with different application schedules to determine if the gel version can be equally effective with fewer daily applications.

What is already known about the treatment

  • Mupirocin (Impetine® Gel)

    A topical antibiotic medication available as a 20 mg/g gel formulation, specifically designed for treating impetigo in pediatric patients. This antibacterial agent works by inhibiting bacterial protein synthesis at the molecular level by binding to bacterial isoleucyl-tRNA synthetase, effectively stopping the growth of skin bacteria. The gel formulation is applied directly to the affected skin areas twice daily, offering a convenient treatment option for superficial skin infections, particularly those caused by Staphylococcus aureus and Streptococcus pyogenes.

  • Mupirocin (Bactroban® Ointment)

    A topical antibiotic medication in a 20 mg/g ointment form, widely used in the treatment of bacterial skin infections, particularly impetigo. This medication functions by preventing bacterial protein synthesis through its interaction with bacterial isoleucyl-tRNA synthetase, effectively eliminating harmful skin bacteria. The ointment is applied to affected areas three times daily and has established itself as a standard treatment option for superficial skin infections, demonstrating consistent effectiveness against common skin pathogens.

Investigated diseases

Impetigo - A highly contagious bacterial skin infection that primarily affects children but can occur at any age. The condition typically begins as small red sores that quickly turn into fluid-filled blisters, which eventually burst and develop honey-colored crusts. These sores most commonly appear around the nose and mouth but can spread to other parts of the body through skin-to-skin contact or by touching contaminated objects. The infection occurs when bacteria enter through breaks in the skin, such as cuts, scrapes, or insect bites. Impetigo usually starts in a small area and can spread to other areas of the body through scratching or touching.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-517475-20-00Protocol codeOP-IPTC02Estimated enrolment464 patientsSponsorLaboratorios Ojer Pharma S.L.

sourced from the EU Clinical Trials Register and site verification

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