ImpetigoPhase 3NCT04287777
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
A Phase 3 study testing Mupirocin gel and Mupirocin ointment in people with Impetigo, run by Reig Jofre Group at 20 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 15 years
- Conditions the study is for
- Impetigo
- What is being tested?
- Mupirocin gel and Mupirocin ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 467 participants
- Where
- 20 sitesSpain
- Study dates
- Feb 2014to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
H.U. Sureste
Arganda, Madrid, 28500
CAP Vallcarca-St. Gervasi
Barcelona, Catalonia, 08023
CAP Corbera de Llobregat
Corbera de Llobregat, Catalonia, 08757
H.U. Fuenlabrada
Fuenlabrada, Madrid, 21942
CAP Castilla la Nueva
Fuenlabrada, Madrid, 28945
CAP Amadeu Torner
L'Hospitalet de Llobregat, Catalonia, 08902
CAP Mossèn Cinto Verdager
L'Hospitalet de Llobregat, Catalonia, 08902
CAP Florida Nord
L'Hospitalet de Llobregat, Catalonia, 08905
CAP Rambla Ferran
Lleida, Catalonia, 25007
CAP Cea Bermúdez
Madrid, 28003
Hospital Gregorio MArañón
Madrid, 28007
CAP Campo de la Paloma
Madrid, 28018
CAP Aravaca
Madrid, 28023
CAP La Calesas
Madrid, 28026
CAP Pinto
Pinto, Madrid, 28320
CAP Pozuelo de Alarcón
Pozuelo de Alarcón, Madrid, 28224
H.U. Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
CAP Torreblanca
Seville, Andalusia, 41016
CAP La Algaba
Seville, Andalusia, 41980
CAP Maria Bernades
Viladecans, Catalonia, 08840
About this study
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
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.
- Conditions
- Impetigo
- Being tested
- Mupirocin gel, Mupirocin ointment, Placebo
- Keywords
- Impetigo, Mupirocin, Mupirocin gel, Mupirocin ointment, Impetigo in children
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin gelDrug
Topical administration of Mupirocin gel 20 mg/g BID for 7 days
Mupirocin ointmentDrug
Also called Bactroban
Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
PlaceboDrug
Topical administration of Placebo (ointment) TID during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Mupirocin gel | Experimental | Topical administration of Mupirocin gel 20 mg/g BID for 7 days Receives: Drug: Mupirocin gel |
| Mupirocin ointment | Active comparator | Topical administration of Mupirocin ointment 20mg/g TID for 7 days. Receives: Drug: Mupirocin ointment |
| Placebo | Placebo comparator | Topical administration of Placebo (ointment) TID for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure at the end of treatment by SIRS assessed by blind observer
Proportion of subjects with clinical cure at the Day 8 visit, assessed by blind observer, according to criteria described in the Protocol (SIRS < or = 2).
Measured: Day 8
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Measured: Day 8
Secondary outcomes (6)
Clinical cure at the end of follow up by SIRS assessed by blind observer
Proportion of subjects with clinical cure at the Day 14 visit, assessed by blind observer, according to criteria described in the protocol (SIRS < or = 2).
Measured: Day14
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14
proportion of subjects with no additional antibiotic therapy required to treat impetigo
Measured: Day14
Total SIRS score at the end of treatment and follow-up by blind observer
Measured: Day 8 and 14
Bacteriology cure at follow-up
Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits
Measured: Day 14
Clinical cure at the end of treatment and follow-up by investigator
Proportion of subjects with clinical cure at the Day 8 and Day 14 visits, assessed by investigator, according to protocol criteria.
Measured: Day 8 and 14
SIRS total score at the end of treatment and follow-up by investigator
SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator
Measured: Day 8 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study startFeb 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpetigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reig Jofre Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raúl De Lucas, Dr., Study director, Hospital La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287777
- Sponsor's protocol ID
- RJ-NBC01
- Status last verified
- Mar 2021
- First submitted
- 29 Oct 2015
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04287777
- Acronym / sponsor ID
- RJ-NBC01
- Conditions
- Impetigo
- Keywords
- Impetigo, Mupirocin, Mupirocin gel, Mupirocin ointment, Impetigo in children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Reig Jofre GroupIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mupirocin gel | Experimental | Drug: Mupirocin gelTopical administration of Mupirocin gel 20 mg/g BID for 7 days |
| Mupirocin ointment | Active comparator | Drug: Mupirocin ointmentTopical administration of Mupirocin ointment 20mg/g TID for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboTopical administration of Placebo (ointment) TID for 7 days |
Who may qualify
- Ages
- 18 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mupirocin gelTopical administration of Mupirocin gel 20 mg/g BID for 7 days | Drug | Mupirocin gel |
| Mupirocin ointmentAlso: BactrobanTopical treatment of Mupirocin ointment 20 mg/g TID for 7 days | Drug | Mupirocin ointment |
| PlaceboTopical administration of Placebo (ointment) TID during 7 days | Drug | Placebo |
Primary outcome
Clinical cure at the end of treatment by SIRS assessed by blind observer
Time frame: Day 8
Proportion of subjects with clinical cure at the Day 8 visit, assessed by blind observer, according to criteria described in the Protocol (SIRS < or = 2).
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8
Time frame: Day 8
proportion of subjects with no additional antibiotic therapy required to treat impetigo
6 secondary outcomes
Clinical cure at the end of follow up by SIRS assessed by blind observer
Time frame: Day14
Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14
Time frame: Day14
Total SIRS score at the end of treatment and follow-up by blind observer
Time frame: Day 8 and 14
Bacteriology cure at follow-up
Time frame: Day 14
Clinical cure at the end of treatment and follow-up by investigator
Time frame: Day 8 and 14
SIRS total score at the end of treatment and follow-up by investigator
Time frame: Day 8 and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raúl De Lucas, Dr. study director
Hospital La Paz
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mupirocin gel and Mupirocin ointment in people with Impetigo, run by Reig Jofre Group at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure at the end of treatment by SIRS assessed by blind observer (time frame: Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.