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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ozenoxacin 1% cream | Experimental | 1% cream |
|
| ozenoxacin placebo | Placebo Comparator | cream |
|
| retapamulin 1% ointment | Active Comparator | 1% ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ozenoxacin placebo | Drug | cream |
| |
| retapamulin 1% ointment |
| 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 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:
Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georg Popp | Augsburg | Germany | ||||
| Klaus Chelius |
| 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. |
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Patients were enrolled at 27 sites in the USA, Germany, Romania, Ukraine, and South Africa.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozenoxacin 1% Cream | 1% cream ozenoxacin 1% cream: 1% cream |
| FG001 | Ozenoxacin Placebo | cream ozenoxacin placebo: cream |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
ointment |
|
| ozenoxacin 1% cream | Drug | 1% cream |
|
| Cologne |
| Germany |
| Roland Aschoff | Dresden | Germany |
| Diamant Thaci | Frankfurt am Main | Germany |
| Stephan Schilling | Mahlow | Germany |
| Ismail Mitha | Benoni | South Africa |
| Johan Lombaard | Bloemfontein | South Africa |
| Jan Fourie | Dundee | South Africa |
| Dawie Kruger | George | South Africa |
| Philip Nel | Hatfield | South Africa |
| Essack Mitha | Johannesburg | South Africa |
| J Trokis | Kraaifontein | South Africa |
| Mohammed Tayob | Middelburg | South Africa |
| Mashra Gani | Port Elizabeth | South Africa |
| Zelda Punt | Port Elizabeth | South Africa |
| Molefe Phayane | Pretoria | South Africa |
| Gail Todd | Rondebosch | South Africa |
| Yacoob Vahed | Welkom | South Africa |
| Christo van Dyk | Worcester | South Africa |
| FG002 | Retapamulin 1% Ointment | 1% ointment retapamulin 1% ointment: ointment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline analysis population was considered the safety populations. The safety population was defined as all patients who had at least one application of study drug.
One patient was randomised to retapamulin but treated with ozenoxacin. One patient was randomised to retapamulin but not treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozenoxacin 1% Cream | 1% cream ozenoxacin 1% cream: 1% cream |
| BG001 | Ozenoxacin Placebo | cream ozenoxacin placebo: cream |
| BG002 | Retapamulin 1% Ointment | 1% ointment retapamulin 1% ointment: ointment |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 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:
Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe | Posted | Number | percentage of participants | 2 weeks |
|
|
|
|
AEs were elicited from signing the informed consent to the completion of the clinical study (including the Final Visit) or premature patient withdrawal from the study (10-13 days)
The safety population was defined as all patients who had at least one application of study drug.
One patient was randomised to retapamulin but treated with ozenoxacin. One patient was randomised to retapamulin but not treated.
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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 1% Cream | 1% cream ozenoxacin 1% cream: 1% cream | 0 | 156 | 0 | 156 | ||
| EG001 | Ozenoxacin Placebo | cream ozenoxacin placebo: cream | 0 | 156 | 0 | 156 | ||
| EG002 | Retapamulin 1% Ointment | 1% ointment retapamulin 1% ointment: ointment | 0 | 152 | 0 | 152 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Ferrer Internacional, S.A. | +34 93 509 32 75 | nalbareda@ferrer.com |
| ID | Term |
|---|---|
| D007169 | Impetigo |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| 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 |
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| ID | Term |
|---|---|
| C508887 | retapamulin |
| D009824 | Ointments |
| C000592413 | ozenoxacin |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| >=12 years to <18 years |
|
| >=18 years to <65 years |
|
| >=65 |
|
| Male |
|
| White |
|
| Mixed race |
|
| Asian |
|
| American Indian or Alaska native |
|