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This is a Phase 1, single center, randomized, vehicle and white petrolatum controlled, evaluator blinded study to assess the skin irritation potential with a range of concentrations of PF-06700841 cream including vehicle and empty patch with white petrolatum under occlusive conditions in adult Japanese healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06700841 cream 0% | Experimental | All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential |
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| PF-06700841 cream 0.1% | Experimental | All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential |
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| PF-06700841 cream 0.3% | Experimental | All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential |
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| PF-06700841 cream 1% | Experimental | All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential |
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| PF-06700841 cream 3% | Experimental | All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06700841 cream | Drug | PF-06700841 will be applied topically |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants who have skin irritation grade equal to or greater than two plus (++) up to Day 4 | Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++) | Up to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants who have skin irritation grade equal to or greater than two plus (++) on each assessment day (Day 3 and Day 4) | Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++) | Day 3 and Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | Osaka | 532-0003 | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| White petrolatum | Experimental | All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential |
|
|
| White petrolatum | Drug | White petrolatum will be applied topically |
|
| The number of the maximum skin irritation score reported up to Day 4 by treatment | Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4) | Up to Day 4 |
| The percentage of the maximum skin irritation score reported up to Day 4 by treatment | Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4) | Up to Day 4 |
| The number of each skin irritation score reported by treatment on each assessment day | Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4) | Day 3 and Day 4 |
| The percentage of each skin irritation score reported by treatment on each assessment day | Skin irritation score is defined as following: no reaction (0); slight erythema (0.5); erythema (1); erythema + edema, papules (2); erythema + edema + papules + vesicles (small blisters) (3) ; large blisters (4) | Day 3 and Day 4 |
| Number of Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Day 35 |
| Number of Participants Discontinuation Due to AEs | Baseline up to Day 35 |