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Clinical trial to evaluate the efficacy and safety of the topical application of Impetine® Gel (mupirocin 20 mg/g) compared with Bactroban® Ointment (mupirocin 20 mg/g) for the treatment of impetigo in paediatric population.
EU CTIS ID: 2024-517475-20-00
What this study is testing
To assess the therapeutic non-inferiority of BID topical administration of Impetine® Gel (mupirocin 20 mg/g) compared to TID administration of Bactroban® Ointment (mupirocin 20 mg/g) in the topical treatment of impetigo (i.e. non-inferiority with dose optimization). Non-inferiority will be evaluated in terms of clinical cure based on Skin Infection Rating Scale (SIRS) at the final study visit [end of follow-up (EOF) (Visit 4)].
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Clinical diagnosis of bullous or non-bullous impetigo.
- Participants in good health, as confirmed by medical history and physical examination, and free of any clinically significant disease/condition, other than impetigo, which could interfere with the study evaluations.
- Impetigo treatable with topical antibiotic in monotherapy.
- Male and female aged between 18 months and 15 years old (inclusive) at the time of signing consent form.
- Suspected positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the target site.
- SIRS total score for the target lesion of at least 4 with at least 3 of the five signs/symptom categories present at baseline (≥ 1)
You likely can't join if
- History of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.
- Having taken part in any clinical research involving medication in the 30 days prior to baseline visit.
- Pregnant, breast feeding, or planning a pregnancy.
- Low level of cooperation foreseen, or non-compliance with treatment.
- Subjects whose disease is so widespread or severe that, in the opinion of the investigator, systemic treatment is needed.
- Any dermatological disorder that may interfere with the evaluation of the subject’s impetigo, including presence of staphylococcal and/or streptococcal ecthyma, cellulitis, furunculosis, abscess, acute dermatitis, contact dermatitis, impetiginized eczema, or impetigo secondary to any human or animal bite.
See the full eligibility criteria
- Clinical diagnosis of bullous or non-bullous impetigo.
- Participants in good health, as confirmed by medical history and physical examination, and free of any clinically significant disease/condition, other than impetigo, which could interfere with the study evaluations.
- Impetigo treatable with topical antibiotic in monotherapy.
- Male and female aged between 18 months and 15 years old (inclusive) at the time of signing consent form.
- Suspected positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the target site.
- SIRS total score for the target lesion of at least 4 with at least 3 of the five signs/symptom categories present at baseline (≥ 1)
- Any type of skin or race providing skin pigmentation allows a correct clinical evaluation of SIRS.
- Informed consent signed by father, mother or legal guardian and, for “mature” minors (12 or more years old), also an informed assent signed by the participant.
- Ability of participant and/or their parents/guardians to understand and comply with requirements of the trial.
- In participants of childbearing potential, a urine pregnancy test with negative result at baseline visit, and females of childbearing potential or male participants, if heterosexually active and with a female partner of childbearing potential or a pregnant or breastfeeding partner, who agree to utilize an adequate form of contraception as defined in Section 8.3 of the Protocol.
- History of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.
- Having taken part in any clinical research involving medication in the 30 days prior to baseline visit.
- Pregnant, breast feeding, or planning a pregnancy.
- Low level of cooperation foreseen, or non-compliance with treatment.
- Subjects whose disease is so widespread or severe that, in the opinion of the investigator, systemic treatment is needed.
- Any dermatological disorder that may interfere with the evaluation of the subject’s impetigo, including presence of staphylococcal and/or streptococcal ecthyma, cellulitis, furunculosis, abscess, acute dermatitis, contact dermatitis, impetiginized eczema, or impetigo secondary to any human or animal bite.
- Primary or secondary immunodeficiency or diabetes mellitus.
- Participants with unstable, life-threatening medical disorders or ongoing malignancies.
- Any medical condition that, in the investigator’s opinion, contraindicates participation of subject in the trial.
- Use of topical corticosteroid, topical antibiotic, or topical antifungal within 48 hours prior to baseline.
- Use of systemic antibiotic or systemic corticosteroid within 1 week prior to baseline.
- Having received cytostatic or immunosuppressant treatment during the three months prior to baseline visit.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.