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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratorios Ojer Pharma S.L.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

13 Oct 2025 → ongoing

Decision date (initial)

2025-06-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Laboratorios Ojer Pharma S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

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)].

Secondary objectives 3

1. To compare the topical BID administration of Impetine® Gel (mupirocin 20 mg/g) with the topical TID administration of Bactroban® Ointment (mupirocin 20 mg/g) for the treatment of impetigo in terms of: • Clinical cure at the end of treatment (EOT) (Visit 3) based on SIRS. • Total SIRS scores at EOT and EOF. • Bacteriological cure at EOF.
2. To compare patient satisfaction with the treatments through a satisfaction questionnaire
3. To evaluate the safety of topical BID administration of Impetine® Gel.

Conditions and MedDRA coding

Impetigo

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Clinical diagnosis of bullous or non-bullous impetigo.
2. Impetigo treatable with topical antibiotic in monotherapy.
3. Male and female aged between 18 months and 15 years old (inclusive) at the time of signing consent form.
4. Suspected positive baseline culture for Staphylococcus aureus and/or Streptococcus pyogenes from a sample taken from the target site.
5. 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)
6. Any type of skin or race providing skin pigmentation allows a correct clinical evaluation of SIRS.
7. 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.
8. Ability of participant and/or their parents/guardians to understand and comply with requirements of the trial.
9. 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.
10. 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.

Exclusion criteria 12

1. History of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.
2. Subjects whose disease is so widespread or severe that, in the opinion of the investigator, systemic treatment is needed.
3. 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.
4. Primary or secondary immunodeficiency or diabetes mellitus.
5. Participants with unstable, life-threatening medical disorders or ongoing malignancies.
6. Any medical condition that, in the investigator’s opinion, contraindicates participation of subject in the trial.
7. Use of topical corticosteroid, topical antibiotic, or topical antifungal within 48 hours prior to baseline.
8. Use of systemic antibiotic or systemic corticosteroid within 1 week prior to baseline.
9. Having received cytostatic or immunosuppressant treatment during the three months prior to baseline visit.
10. Having taken part in any clinical research involving medication in the 30 days prior to baseline visit.
11. Pregnant, breast feeding, or planning a pregnancy.
12. Low level of cooperation foreseen, or non-compliance with treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical cure at EOF – Visit 4 measured as the proportion of subjects with clinical cure based on SIRS according to the blinded assessor.

Secondary endpoints 7

1. Clinical cure at EOT – Visit 3 measured as the proportion of subjects with clinical cure based on SIRS according to the blinded assessor.
2. Clinical cure at EOT and EOF measured as the proportion of subjects with clinical cure based on SIRS according to the investigator.
3. Total SIRS scores at EOT and EOF according to the blinded assessor.
4. Total SIRS scores at EOT and EOF according to the investigator.
5. Bacteriological cure at EOF.
6. Treatment satisfaction at EOT.
7. Incidence of adverse events.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorios Ojer Pharma S.L.

Sponsor organisation

Laboratorios Ojer Pharma S.L.

Address

Avenida De Pio XII 4 Piso 1 A

City

Pamplona

Postcode

31007

Country

Spain

Scientific contact point

Organisation

Laboratorios Ojer Pharma S.L.

Contact name

Clinical Development Manager

Public contact point

Organisation

Laboratorios Ojer Pharma S.L.

Contact name

Clinical Development Manager

Third parties 7

Locations

1 EU/EEA country · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications