Impetigo
Conditions
Brief summary
This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.
Interventions
DRUGOzenoxacin
DRUGPlacebo
Sponsors
Ferrer Internacional S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months 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 3, 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 | Visit 3 (Day 6-7) | Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain. |
Countries
Puerto Rico
Participant flow
Recruitment details
Patients were enrolled at 34 sites in Germany, Puerto Rico, Romania, Russia, South Africa, Spain and the United States of America (USA).
Participants by arm
| Arm | Count |
|---|---|
| Ozenoxacin ozenoxacin cream 1%
Ozenoxacin | 206 |
| Placebo Placebo cream
Placebo | 205 |
| Total | 411 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Intercurrent illness and other | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 13 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Ozenoxacin | Placebo | Total |
|---|---|---|---|
| Age, Customized >=12 years to <18 years | 23 participants | 23 participants | 46 participants |
| Age, Customized >=18 years | 69 participants | 70 participants | 139 participants |
| Age, Customized >= 2 months to <12 years | 114 participants | 112 participants | 226 participants |
| Race/Ethnicity, Customized Asian | 16 participants | 15 participants | 31 participants |
| Race/Ethnicity, Customized Black | 53 participants | 38 participants | 91 participants |
| Race/Ethnicity, Customized Caucasian | 122 participants | 139 participants | 261 participants |
| Race/Ethnicity, Customized Mixed Race | 15 participants | 13 participants | 28 participants |
| Region of Enrollment Germany | 21 participants | 16 participants | 37 participants |
| Region of Enrollment Puerto Rico | 23 participants | 23 participants | 46 participants |
| Region of Enrollment Romania | 26 participants | 26 participants | 52 participants |
| Region of Enrollment Russian Federation | 27 participants | 30 participants | 57 participants |
| Region of Enrollment South Africa | 43 participants | 34 participants | 77 participants |
| Region of Enrollment Spain | 1 participants | 2 participants | 3 participants |
| Region of Enrollment United States | 65 participants | 74 participants | 139 participants |
| Sex: Female, Male Female | 94 Participants | 107 Participants | 201 Participants |
| Sex: Female, Male Male | 112 Participants | 98 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 206 | 0 / 205 |
| serious Total, serious adverse events | 0 / 206 | 0 / 205 |
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 success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain.
Time frame: Visit 3 (Day 6-7)
Population: Intent-to-treat clinical (ITTC) population was defined as all randomized patients.~The % of clinical success for the treatment comparison were calculated excluding the unable to determine: OZN (112/203), PLB (78/199)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ozenoxacin | Clinical Success | 55.2 percentage of Participants |
| Placebo | Clinical Success | 39.2 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) was provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.p-value: 0.001Chi-squared