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The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clobex Spray | Active Comparator |
| |
| Vehicle spray | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clobetasol propionate spray 0.05% | Drug | Apply enough product to cover affected areas topically twice daily at least 8 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear) | Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4). | baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research Associates | Los Angeles | California | 90045 | United States | ||
| Hudson Dermatology |
Wash-out period to baseline: 14 days: chemical hair process, steroid medication and/or ultraviolet B (UVB) treatment, calcipotriene, other vitamin D analogs, Anthralin/tar, all other anti-psoriasis medications; 4 wks: psoralen & UVA (PUVA) treatment & treatments other than biologics with possible efficacy on psoriasis; 12 wks: biological therapies
Dates of recruitment period: First subject was enrolled on April 20, 2009 and the last subject was enrolled on November 17, 2009.
Types of location: Investigative sites were located at private physician offices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clobex Spray | |
| FG001 | Vehicle Spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Vehicle spray | Drug | Apply enough product to cover affected areas topically twice daily at least 8 hours apart |
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| baseline to week 4 |
| Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst. | baseline to week 4 |
| Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst. | baseline to week 4 |
| Evansville |
| Indiana |
| 47714 |
| United States |
| Research Division of The Skin Specialty Group | New York | New York | 10155 | United States |
| Dermatology Associates, PLLC | Seattle | Washington | 98101 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clobex Spray | |
| BG001 | Vehicle Spray | |
| BG002 | Total | Total of all reporting groups |
| 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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| 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 | ||||||||||||||||||||||||||||||
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| Secondary | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst. | Posted | Number | participants | baseline to week 4 |
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| Secondary | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst. | Posted | Number | participants | baseline to week 4 |
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| Secondary | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst. | Posted | Number | participants | baseline to week 4 |
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| Primary | Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear) | Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4). | ITT, LOCF | Posted | Number | participants | baseline to week 4 |
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4 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.
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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 | 0 | 41 | 0 | 41 | |||
| EG001 | Vehicle Spray | 0 | 40 | 0 | 40 |
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The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald W. Gottschalk, MD / Medical Director | Galderma Laboratories, L.P. | 817-961-5358 | ron.gottschalk@galderma.com |
| Male |
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| Scaling Baseline Mild (1) |
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| Scaling Week 4 Mild (1) |
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| Scaling Baseline Moderate (2) |
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| Scaling Week 4 Moderate (2) |
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| Scaling Baseline Severe (3) |
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| Scaling Week 4 Severe (3) |
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| Scaling Baseline Very Severe (4) |
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| Scaling Week 4 Very Severe (4) |
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| Erythema Baseline None (0) |
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| Erythema Week 4 None (0) |
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| Erythema Baseline Mild (1) |
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| Erythema Week 4 Mild (1) |
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| Erythema Baseline Moderate (2) |
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| Erythema Week 4 Moderate (2) |
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| Erythema Baseline Severe (3) |
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| Erythema Week 4 Severe (3) |
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| Erythema Baseline Very Severe (4) |
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| Erythema Week 4 Very Severe (4) |
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| Plaque Elevation Baseline None (0) |
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| Plaque Elevation Week 4 None (0) |
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| Plaque Elevation Baseline Mild (1) |
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| Plaque Elevation Week 4 Mild (1) |
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| Plaque Elevation Baseline Moderate (2) |
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| Plaque Elevation Week 4 Moderate (2) |
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| Plaque Elevation Baseline Severe (3) |
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| Plaque Elevation Week 4 Severe (3) |
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| Plaque Elevation Baseline Very Severe (4) |
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| Plaque Elevation Week 4 Very Severe (4) |
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