Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 2 study evaluating the safety, tolerability, systemic exposure, and activity of topical ATx201 GEL (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary nonbullous or bullous impetigo.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ATx201 GEL 2% | Experimental |
| |
| Group 2: ATx201 GEL 4% | Experimental |
| |
| Group 3: ATx201 GEL 4% plus vehicle | Experimental |
| |
| Group 4: ATx201 GEL 4% plus vehicle | Experimental |
| |
| Group 5: Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATx201 | Drug | ATx201 GEL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of Adverse Events and Laboratory Parameters | incidences of adverse events reports and changes in significant laboratory parameters | 14 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippe Prokocimer, MD | CMO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AntibioTx Investigational Site | Bloemfontein | South Africa | ||||
| AntibioTx Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects will be randomly assigned (stratified by age) by using an Interactive Web Response System (IWRS) to one of five treatment groups
Not provided
Not provided
Not provided
| ATx201 GEL Vehicle | Other | Vehicle |
|
| Boksburg |
| South Africa |
| AntibioTx Investigative Site | Claremont | South Africa |
| AntibioTx Investigative Site | Durban | South Africa |
| AntibioTx Investigative Site | eMkhomazi | South Africa |
| AntibioTx Investigative Site | Germiston | South Africa |
| AntibioTx Investigative Site 2 | Johannesburg | South Africa |
| AntibioTx Investigative Site | Johannesburg | South Africa |
| AntibioTx Investigative Site | Kraaifontein | South Africa |
| AntibioTx Investigative Site | Mpumalanga | South Africa |
| AntibioTx Investigative Site | Paarl | South Africa |
| AntibioTx Investigative Site 2 | Port Elizabeth | South Africa |
| AntibioTx Investigative Site | Port Elizabeth | South Africa |
| AntibioTx Investigative Site | Pretoria | South Africa |
| AntibioTx Investigative Site | Soshanguve | South Africa |
| AntibioTx Investigative Site | Winnie Mandela | South Africa |
| 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 |
Not provided
Not provided