Clinical trial NCT04287777: Safety and Efficacy of Mupirocin Gel in Children With Impetigo
Official title: Ph-III Randomized, Multicentric, Controlled , Non-inferiority Trial to Evaluate the Safety and Efficacy of Mupirocin Gel 20 mg/g Versus Mupirocin Ointment 20 mg/g and Placebo in the Treatment of Impetigo in Paediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impetigo
Keywords: Impetigo
Mupirocin
Mupirocin gel
Mupirocin ointment
Impetigo in children
Lead sponsor: Reig Jofre Group
Sponsor class: INDUSTRY
First posted: 2020-02-27
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Ointment 20 mg/g TID (three times daily) (Bactroban) in the treatment of impetigo in paediatric population.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Clinical cure at the end of treatment by SIRS assessed by blind observer
timeFrame: Day 8
measure: Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8
timeFrame: Day 8
Secondary outcomes:
measure: Clinical cure at the end of follow up by SIRS assessed by blind observer
timeFrame: Day14
measure: Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14
timeFrame: Day14
measure: Total SIRS score at the end of treatment and follow-up by blind observer
timeFrame: Day 8 and 14
measure: Bacteriology cure at follow-up
timeFrame: Day 14
measure: Clinical cure at the end of treatment and follow-up by investigator
timeFrame: Day 8 and 14
measure: SIRS total score at the end of treatment and follow-up by investigator
timeFrame: Day 8 and 14
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: CAP Torreblanca
state: Andalucia
city: Sevilla
country: Spain
facility: CAP La Algaba
state: Andalucia
city: Barcelona
country: Spain
facility: CAP Vallcarca-St. Gervasi
state: Catalonia
city: Corbera De Llobregat
country: Spain
facility: CAP Corbera de Llobregat
state: Catalonia
city: L'Hospitalet De Llobregat
country: Spain
facility: CAP Amadeu Torner
state: Catalonia
city: L'Hospitalet de Llobregat
country: Spain
facility: CAP Mossèn Cinto Verdager
state: Catalonia
city: L'HOspitalet de Llobregat
country: Spain
facility: CAP Florida Nord
state: Catalonia
city: Lleida
country: Spain
facility: CAP Rambla Ferran
state: Catalonia
city: Viladecans
country: Spain
facility: CAP Maria Bernades
state: Catalonia
city: Arganda del Rey
country: Spain
facility: H.U. Sureste
state: Madrid
city: Fuenlabrada
country: Spain
facility: H.U. Fuenlabrada
state: Madrid
city: Fuenlabrada
country: Spain
facility: CAP Castilla la Nueva
state: Madrid
city: Pinto
country: Spain
facility: CAP Pinto
state: Madrid
city: Pozuelo de Alarcón
country: Spain
facility: CAP Pozuelo de Alarcón
state: Madrid
city: San Sebastián de los Reyes
country: Spain
facility: H.U. Infanta Sofía
state: Madrid
city: Madrid
country: Spain
facility: CAP Cea Bermúdez
city: Madrid
country: Spain
facility: Hospital Gregorio MArañón
city: Madrid
country: Spain
facility: CAP Campo de la Paloma
city: Madrid
country: Spain
facility: CAP Aravaca
city: Madrid
country: Spain
facility: CAP La Calesas
Study officials:
affiliation: Hospital La Paz
name: Raúl De Lucas, Dr.
role: STUDY_DIRECTOR
References: