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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozenoxacin | Experimental | ozenoxacin cream 1% |
|
| Placebo | Placebo Comparator | Placebo cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozenoxacin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 3 (Day 6-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caparra Internal Medicine Center | Rio Grande | Puerto Rico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30365584 | Derived | Hebert AA, Albareda N, Rosen T, Torrelo A, Grimalt R, Rosenberg N, Zsolt I, Masramon X. Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials. J Drugs Dermatol. 2018 Oct 1;17(10):1051-1057. | |
| 29898217 | Derived | Rosen T, Albareda N, Rosenberg N, Alonso FG, Roth S, Zsolt I, Hebert AA. Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jul 1;154(7):806-813. doi: 10.1001/jamadermatol.2018.1103. |
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Patients were enrolled at 34 sites in Germany, Puerto Rico, Romania, Russia, South Africa, Spain and the United States of America (USA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozenoxacin | ozenoxacin cream 1% Ozenoxacin |
| FG001 | Placebo | Placebo cream Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population was consider the safety population. Safety population was defined as all patients who received at least one application of study drug.
One patient was randomised to placebo but never treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozenoxacin | ozenoxacin cream 1% Ozenoxacin |
| BG001 | Placebo | Placebo cream Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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) | Posted | Number | percentage of Participants | Visit 3 (Day 6-7) |
|
AEs were elicited from signing the informed consent to the completion of the clinical study (including the Follow up Visit) or premature patient withdrawal from the study. (10-13 days)
The safety population was defined as all patients who recieved at least one application of study drug. One patient was randomised to placebo but never received any treatment.Tthat is why there are only 205 patienst in the placebo group in the safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ozenoxacin | ozenoxacin cream 1% Ozenoxacin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Ferrer Internacional, S.A. | +34 93 509 32 75 | nalbareda@ferrer.com |
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| ID | Term |
|---|---|
| D007169 | Impetigo |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C000592413 | ozenoxacin |
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|
| Withdrawal by Subject |
|
| Intercurrent illness and other |
|
| Lost to Follow-up |
|
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Placebo cream Placebo |
|
|
|
| 0 |
| 206 |
| 0 |
| 206 |
| EG001 | Placebo | Placebo cream Placebo | 0 | 205 | 0 | 205 |
Any and all data resulting from the Study will not be presented or published in any form or media by the Institution, Investigator or Research Staff without the prior written consent of Sponsor which consent maybe as directed within the Protocol.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |