Scalp Psoriasis
Conditions
Brief summary
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.
Interventions
Apply enough product to cover affected areas topically twice daily at least 8 hours apart
DRUGVehicle spray
Apply enough product to cover affected areas topically twice daily at least 8 hours apart
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp
Exclusion criteria
* Subjects who need systemic treatment for their body psoriasis * Subjects who have surface area involvement too large (\>20% Body Surface Area \[BSA\]) that would require more than 50 grams per week of study product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | baseline to week 4 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | baseline to 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. |
| Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | baseline to 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. |
| Number of Participants in Each Category of Pruritus at Baseline and Week 4 | baseline to 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Clobex Spray | 41 |
| Vehicle Spray | 40 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Physician Decision | 4 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | Clobex Spray | Vehicle Spray | Total |
|---|---|---|---|
| Age, Continuous | 46.0 years STANDARD_DEVIATION 15.41 | 41.3 years STANDARD_DEVIATION 13.72 | 43.7 years STANDARD_DEVIATION 14.69 |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 40 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 |
Outcome results
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).
Time frame: baseline to week 4
Population: ITT, LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clobex Spray | 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) | Success | 35 participants |
| Clobex Spray | 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) | Failure | 6 participants |
| Vehicle Spray | 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) | Success | 5 participants |
| Vehicle Spray | 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) | Failure | 35 participants |
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.
Time frame: baseline to week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clobex Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Baseline None (0) | 4 participants |
| Clobex Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Baseline Moderate (2) | 29 participants |
| Clobex Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Week 4 Moderate (2) | 1 participants |
| Clobex Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Baseline Mild (1) | 5 participants |
| Clobex Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Baseline Severe (3) | 3 participants |
| Clobex Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Week 4 None (0) | 28 participants |
| Clobex Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Week 4 Severe (3) | 0 participants |
| Clobex Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Week 4 Mild (1) | 12 participants |
| Vehicle Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Week 4 Severe (3) | 4 participants |
| Vehicle Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Baseline Moderate (2) | 24 participants |
| Vehicle Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Week 4 None (0) | 8 participants |
| Vehicle Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Baseline Mild (1) | 10 participants |
| Vehicle Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Week 4 Mild (1) | 14 participants |
| Vehicle Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Week 4 Moderate (2) | 14 participants |
| Vehicle Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Baseline Severe (3) | 5 participants |
| Vehicle Spray | Number of Participants in Each Category of Pruritus at Baseline and Week 4 | Pruritus Baseline None (0) | 1 participants |
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.
Time frame: baseline to week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline None | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 None | 21 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline <20% | 16 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 <20% | 16 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline 20-39% | 5 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 20-39% | 4 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline 40-59% | 12 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 40-59% | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline 60-79% | 6 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 60-79% | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline 80-100% | 2 participants |
| Clobex Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 80-100% | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline 80-100% | 3 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline None | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline 40-59% | 14 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 None | 1 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 60-79% | 5 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline <20% | 12 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 40-59% | 4 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 <20% | 16 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 80-100% | 2 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline 20-39% | 6 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Baseline 60-79% | 5 participants |
| Vehicle Spray | Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 | Extent of Scalp Involvement Week 4 20-39% | 12 participants |
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.
Time frame: baseline to week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 Moderate (2) | 3 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline Very Severe (4) | 3 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline Severe (3) | 8 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 None (0) | 24 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 Severe (3) | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 Very Severe (4) | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline Very Severe (4) | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 Moderate (2) | 1 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 Very Severe (4) | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline None (0) | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline None (0) | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 Mild (1) | 15 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 None (0) | 26 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 None (0) | 24 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline Mild (1) | 7 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline Severe (3) | 12 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 Mild (1) | 13 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline Mild (1) | 3 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline Moderate (2) | 19 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline Mild (1) | 4 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 Moderate (2) | 1 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 Mild (1) | 14 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline Severe (3) | 13 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 Severe (3) | 1 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 Severe (3) | 1 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline Moderate (2) | 30 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline Very Severe (4) | 2 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline Moderate (2) | 22 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 Very Severe (4) | 0 participants |
| Clobex Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline None (0) | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 Very Severe (4) | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline None (0) | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 None (0) | 3 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline Mild (1) | 2 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 Mild (1) | 9 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline Moderate (2) | 26 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 Moderate (2) | 21 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline Severe (3) | 11 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 Severe (3) | 7 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Baseline Very Severe (4) | 1 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Scaling Week 4 Very Severe (4) | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline None (0) | 1 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 None (0) | 3 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline Mild (1) | 4 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 Mild (1) | 11 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline Moderate (2) | 26 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 Moderate (2) | 20 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline Severe (3) | 9 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 Severe (3) | 6 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Baseline Very Severe (4) | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Erythema Week 4 Very Severe (4) | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline None (0) | 0 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 None (0) | 7 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline Mild (1) | 2 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 Mild (1) | 12 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline Moderate (2) | 27 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 Moderate (2) | 19 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline Severe (3) | 11 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Week 4 Severe (3) | 2 participants |
| Vehicle Spray | Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 | Plaque Elevation Baseline Very Severe (4) | 0 participants |