Impetigo
Conditions
Brief summary
This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.
Interventions
Sponsors
Ferrer Internacional S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients \< 12 years the total area will not exceed a maximum of 2% of the body surface area. * Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1
Exclusion criteria
* Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic. * Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 2 weeks | Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The SIRS is a severity index based on seven signs or symptoms: * Exudate/pus * Crusting * Erythema/inflammation * Tissue warmth * Tissue oedema * Itching * Pain Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe |
Countries
Germany, South Africa
Participant flow
Recruitment details
Patients were enrolled at 27 sites in the USA, Germany, Romania, Ukraine, and South Africa.
Participants by arm
| Arm | Count |
|---|---|
| Ozenoxacin 1% Cream 1% cream
ozenoxacin 1% cream: 1% cream | 156 |
| Ozenoxacin Placebo cream
ozenoxacin placebo: cream | 156 |
| Retapamulin 1% Ointment 1% ointment
retapamulin 1% ointment: ointment | 152 |
| Total | 464 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 3 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 |
| Overall Study | Not treated | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Ozenoxacin 1% Cream | Ozenoxacin Placebo | Retapamulin 1% Ointment |
|---|---|---|---|---|
| Age, Customized >=12 years to <18 years | 52 Participants | 19 Participants | 18 Participants | 15 Participants |
| Age, Customized >=18 years to <65 years | 116 Participants | 36 Participants | 40 Participants | 40 Participants |
| Age, Customized 2>=years to <12 years | 283 Participants | 95 Participants | 94 Participants | 94 Participants |
| Age, Customized >=65 | 13 Participants | 6 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska native | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 233 Participants | 78 Participants | 77 Participants | 78 Participants |
| Race/Ethnicity, Customized Mixed race | 56 Participants | 19 Participants | 15 Participants | 22 Participants |
| Race/Ethnicity, Customized White | 170 Participants | 58 Participants | 62 Participants | 50 Participants |
| Sex: Female, Male Female | 178 Participants | 56 Participants | 60 Participants | 62 Participants |
| Sex: Female, Male Male | 286 Participants | 100 Participants | 96 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 156 | 0 / 156 | 0 / 152 |
| serious Total, serious adverse events | 0 / 156 | 0 / 156 | 0 / 152 |
Outcome results
Primary
Clinical Success
Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The SIRS is a severity index based on seven signs or symptoms: * Exudate/pus * Crusting * Erythema/inflammation * Tissue warmth * Tissue oedema * Itching * Pain Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ozenoxacin 1% Cream | Clinical Success | 34.8 percentage of participants |
| Ozenoxacin Placebo | Clinical Success | 19.2 percentage of participants |
| Retapamulin 1% Ointment | Clinical Success | 37.7 percentage of participants |
Comparison: The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) and corresponding 95% asymptotic (Wald) CI for the difference in success rates for the ozenoxacin versus placebo were provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.~Text extracted from the statistical analysis plan. No additional data was pre-specified for the statistical comparisonp-value: 0.003Chi-squared