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The aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with Clobex spray treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clobex spray | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobex Spray | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Target Lesion Severity Score. | Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Reported Target Lesion Severity Score | Investigator reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fasahat Hamzavi, MD | Hamzavi Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clobex Spray | Clobex Spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clobex Spray | Clobex Spray |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Subject Reported Target Lesion Severity Score. | Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Secondary | Investigator Reported Target Lesion Severity Score | Investigator reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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From baseline up to Day 15
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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 | Clobex Spray | Clobex Spray | 0 | 28 | 0 | 28 | 4 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin plaque | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Project Manager | Galderma Laboratories, L.P. | 817-961-5000 | jay.mashburn@galderma.com |
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