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This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3 concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in healthy subjects. Results from this study will be considered when selecting the concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30 evaluable subjects complete the study. The total duration of subject participation may be up to 50 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2894512 0.5% | Experimental | Each subject will receive a topical application of GSK2894512 0.5% under semi-occlusive patch conditions once daily (OD) for 21 days. |
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| GSK2894512 1% | Experimental | Each subject will receive a topical application of GSK2894512 1% under semi- occlusive patch conditions OD for 21 days. |
|
| GSK2894512 2% | Experimental | Each subject will receive a topical application of GSK2894512 2% under semi-occlusive patch conditions OD for 21 days. |
|
| Vehicle | Placebo Comparator | Each subject will receive a topical application of Vehicle cream under semi-occlusive patch conditions OD for 21 days. |
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| Sodium lauryl sulfate 0.1% | Active Comparator | Each subject will receive a topical application of 0.2 milliliter (mL) of Sodium lauryl sulfate under semi-occlusive patch conditions OD for 21 days. This will serve as a positive control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2894512 cream | Drug | GSK2894512 is a white to off-white cream that will be applied topically in 3 different concentrations (0.5% [5 milligram (mg)/gram (g)], 1% [10 mg/g], and 2% [20 mg/g]). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean cumulative irritation score | It is the sum of dermal response irritation scores from Day 2 through Day 22 divided by the number of non-missing observations | 21 Days |
| Total cumulative irritation score | It is the sum of dermal response irritation scores from Day 2 through Day 22 | 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and treatment-related AEs | All AEs and serious adverse events will be collected from the time a subject consents to participate in the study through the final study visit | Up to Day 22 |
| Change from baseline in vital signs |
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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 | Baltimore | Maryland | 21225 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study 117191 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 117191 | Study Protocol | 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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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Petrolatum | Active Comparator | Each subject will receive a topical application of 0.2 mL of Petrolatum under semi-occlusive patch conditions OD for 21 days. This will serve as a negative control. |
|
| Vehicle cream | Drug | Vehicle cream does not contain any active pharmaceutical ingredient. |
|
| Positive control | Drug | Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g). |
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| Negative control | Drug | Negative control contains petrolatum. |
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Vital signs include heart rate, blood pressure, and oral temperature |
| Screening, Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20 and Day 22 |
| Change from baseline in clinical laboratory parameters | Laboratory parameters include haematology and, clinical chemistry tests | Screening, Day 11 (+/-2 days) and Day 22 |
| Change from baseline in electrocardiogram (ECG) findings | Single 12-lead ECGs will be obtained using an ECG machine to monitor cardiac safety | Screening, Day 11 (+/-2 days) and Day 22 (+/-2 days) |
| Plasma trough concentrations of GSK2894512 | Trough concentration is the minimum concentration of GSK2894512 observed after its administration and just prior to the administration of a subsequent dose | Day 11 (+/- 2 days) and Day 22 |
| Hamburg |
| 20095 |
| Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 117191 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117191 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117191 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117191 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117191 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |