Status:
COMPLETED
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
Lead Sponsor:
Reig Jofre Group
Conditions:
Impetigo
Eligibility:
All Genders
18-15 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to show non inferiority in terms of safety and efficacy of topical administration BID (Twice daily) of Mupirocin Gel 20 mg/g compared to topical administration of Mupirocin...
Eligibility Criteria
Inclusion
- Age between 18 months and 15 years at the signature of informed consent
- Impetigo susceptible to be treated with topical mupirocin and non requiring systemic antibiotic treatment (maximum of 4 different affected areas and no fever).
- Global score of Skin Infection Rating Scale (SIRS) ≥ 4, with positive value (≥ 1) in at least 3 of the 5 categories evaluated.
- Signature of informed consent by parent or legal tutor and, in case of mature minor (12 years or more), signature of informed assent.
- Patient or parent's ability to understand and fulfill with protocol requirements.
- In potentially pregnant patients, negative pregnancy urine test at baseline and use of reliable contraception double barrier methods during the trial.
Exclusion
- Allergy to any compound of the trial treatments
- Have received systemic treatment with antibiotics or steroids, during the week prior to the baseline visit.
- Have received topical treatment with corticosteroids, antibiotics or antifungals, during the 48 hours prior to the baseline visit.
- Primary or secondary immunodeficiency.
- Have received cytostatic or immunosuppressive treatment three months prior to baseline.
- Any skin disorder that could interfere with the evaluation of the results of impetigo, such as presence of staphylococcal or streptococcal ecthyma, cellulitis, furunculosis, acute dermatitis, contact dermatitis or impetiginized eczema.
- Diabetes mellitus.
- Infection that, in the investigator's opinion, should be treated with systemic antibiotic.
- Any medical condition which, in the investigator's opinion, contraindicates the subject's participation in the trial.
- Forecast of little cooperation, non-compliance with medical treatment or low credibility.
- Have participated in any clinical investigation with medicine within 30 days prior to basal visit.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT04287777
Start Date
February 1 2014
End Date
November 1 2016
Last Update
March 12 2021
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
CAP Torreblanca
Seville, Andalusia, Spain, 41016
2
CAP La Algaba
Seville, Andalusia, Spain, 41980
3
CAP Vallcarca-St. Gervasi
Barcelona, Catalonia, Spain, 08023
4
CAP Corbera de Llobregat
Corbera de Llobregat, Catalonia, Spain, 08757