Mupirocin for Impetigo

Inclusion criteria

• {"criterion_text":"- Clinical diagnosis of bullous or non-bullous impetigo.\n- 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.\n- Impetigo treatable with topical antibiotic in monotherapy.\n- Male and female aged between 18 months and 15 years old (inclusive) at the time of signing consent form.\n- Suspected positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the target site.\n- 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)\n- Any type of skin or race providing skin pigmentation allows a correct clinical evaluation of SIRS.\n- 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.\n- Ability of participant and/or their parents/guardians to understand and comply with requirements of the trial.\n- 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."}

Exclusion criteria

• {"criterion_text":"- History of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.\n- Subjects whose disease is so widespread or severe that, in the opinion of the investigator, systemic treatment is needed.\n- 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.\n- Primary or secondary immunodeficiency or diabetes mellitus.\n- Participants with unstable, life-threatening medical disorders or ongoing malignancies.\n- Any medical condition that, in the investigator’s opinion, contraindicates participation of subject in the trial.\n- Use of topical corticosteroid, topical antibiotic, or topical antifungal within 48 hours prior to baseline.\n- Use of systemic antibiotic or systemic corticosteroid within 1 week prior to baseline.\n- Having received cytostatic or immunosuppressant treatment during the three months prior to baseline visit.\n- Having taken part in any clinical research involving medication in the 30 days prior to baseline visit.\n- Pregnant, breast feeding, or planning a pregnancy.\n- Low level of cooperation foreseen, or non-compliance with treatment."}

Primary endpoints

• {"endpoint_text":"- Clinical cure at EOF – Visit 4 measured as the proportion of subjects with clinical cure based on SIRS according to the blinded assessor.","definition_or_measurement_approach":"Measured as the proportion of subjects with clinical cure based on the Skin Infection Rating Scale (SIRS) at end of follow-up (EOF, Visit 4) as assessed by a blinded assessor."}

Secondary endpoints

• {"endpoint_text":"- Clinical cure at EOT – Visit 3 measured as the proportion of subjects with clinical cure based on SIRS according to the blinded assessor.","definition_or_measurement_approach":"Proportion with clinical cure at end of treatment (EOT, Visit 3) based on SIRS evaluated by blinded assessor."}
• {"endpoint_text":"- Clinical cure at EOT and EOF measured as the proportion of subjects with clinical cure based on SIRS according to the investigator.","definition_or_measurement_approach":"Proportion with clinical cure at EOT and EOF based on SIRS evaluated by the investigator."}
• {"endpoint_text":"- Total SIRS scores at EOT and EOF according to the blinded assessor.","definition_or_measurement_approach":"Total Skin Infection Rating Scale (SIRS) scores at EOT and EOF as assessed by blinded assessor."}
• {"endpoint_text":"- Total SIRS scores at EOT and EOF according to the investigator.","definition_or_measurement_approach":"Total SIRS scores at EOT and EOF as assessed by the investigator."}
• {"endpoint_text":"- Bacteriological cure at EOF.","definition_or_measurement_approach":"Bacteriological cure assessed at end of follow-up (EOF) from baseline and follow-up cultures of the target site."}
• {"endpoint_text":"- Treatment satisfaction at EOT.","definition_or_measurement_approach":"Patient/parent treatment satisfaction measured at end of treatment (EOT) using a satisfaction questionnaire (D4 Satisfaction Questionnaire document listed)."}
• {"endpoint_text":"- Incidence of adverse events.","definition_or_measurement_approach":"Recording and reporting of adverse events throughout the study period; incidence summarized as safety endpoint."}

Spain

Earliest CTIS Part Ii Submission Date

19-06-2025

Latest Decision Or Authorization Date

27-06-2025

Processing Time Days

8

Number Of Sites

26

Number Of Participants

464

Primary sponsor

Full Name

Laboratorios Ojer Pharma S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Hospital Sant Joan De Deu Barcelona","duties_or_roles":"13","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"1,11,12,2,5,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Fundacio Privada Dau","duties_or_roles":"14","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Spain","full_name":"Laboratorio Echevarne S.A.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Spain","full_name":"Hospital Universitario De Navarra","duties_or_roles":"13","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Spain","full_name":"Hospital HM Nens","duties_or_roles":"13","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Spain","full_name":"University Hospital Son Espases","duties_or_roles":"13","organisation_type":"Hospital/Clinic/Other health care facility"}