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The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective than a placebo ointment in the treatment of primary impetigo.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-275833 ointment, 1% | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits. |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bangalore | 560 054 | India | |||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| TOC103469 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Hyderabad |
| 40000 |
| India |
| GSK Investigational Site | Rome | Lazio | 00133 | Italy |
| GSK Investigational Site | Zapopan, Jalisco | Jalisco | 45190 | Mexico |
| GSK Investigational Site | Mexico City | 06780 | Mexico |
| GSK Investigational Site | Beek en Donk | 5741 CG | Netherlands |
| GSK Investigational Site | Deurne | 5751 XJ | Netherlands |
| GSK Investigational Site | Ermelo | 3851 EX | Netherlands |
| GSK Investigational Site | Gouda | 2806 DA | Netherlands |
| GSK Investigational Site | Musselkanaal | 9581 AD | Netherlands |
| GSK Investigational Site | Musselkanaal | 9581 AJ | Netherlands |
| GSK Investigational Site | Nijmegen | 6531 NB | Netherlands |
| GSK Investigational Site | Nijverdal | 7442 LS | Netherlands |
| GSK Investigational Site | Roelofarendsveen | 2371 RB | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 GE | Netherlands |
| GSK Investigational Site | Rotterdam | 3082 DC | Netherlands |
| GSK Investigational Site | Soerendonk | 6027 RN | Netherlands |
| GSK Investigational Site | Woerden | 3443 GG | Netherlands |
| GSK Investigational Site | Zieuwent | 7136 KH | Netherlands |
| GSK Investigational Site | Zwijndrecht | 3331 LZ | Netherlands |
| GSK Investigational Site | Callao | Provincia Constitucional del Callao | Callao 1 | Peru |
| GSK Investigational Site | Lima | Lima 31 | Peru |
For additional information about this study please refer to the GSK Clinical Study Register |
| TOC103469 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC103469 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC103469 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC103469 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC103469 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC103469 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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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