The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Calcipotriene Foam	Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.
Vehicle Foam	Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.

Participant Flow:   Overall Study

	Calcipotriene Foam	Vehicle Foam
STARTED	181	182
COMPLETED	158	164
NOT COMPLETED	23	18
Adverse Event	5	4
Lost to Follow-up	9	1
Lack of Efficacy	0	2
Withdrawal by Subject	6	9
Used Excluded Medicine After Enrollment	1	0
Did Not Meet Exclusion Criteria	1	0
Misrandomized	1	0
Beginning Study Exclusion Treatment	0	1
Participant Randomization in Error	0	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Calcipotriene Foam	Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Vehicle Foam	Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
Total	Total of all reporting groups

Baseline Measures

	Calcipotriene Foam	Vehicle Foam	Total
Overall Participants Analyzed  [Units: Participants]	181	182	363
Age  [Units: Years] Mean (Standard Deviation)	45.9  (15.3)	44.4  (15.5)	45.2  (15.4)
Gender  [Units: Participants] Count of Participants
Female	69  38.1%	76  41.8%	145  39.9%
Male	112  61.9%	106  58.2%	218  60.1%
Race/Ethnicity, Customized  [Units: Participants]
American Indian or Alaska Native	2	0	2
Asian	6	3	9
Black	15	18	33
Multiracial	1	1	2
Native Hawaiian/Other Pacific Islander	0	0	0
White	156	160	316
Missing	1	0	1

1.  Primary:

Number of Participants With an Investigator’s Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method   [ Time Frame: Week 8 ]

2.  Primary:

Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)   [ Time Frame: Week 8 ]

3.  Secondary:

Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8   [ Time Frame: Baseline and Week 8 ]

4.  Secondary:

Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8   [ Time Frame: Baseline and Week 8 ]

5.  Secondary:

Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8   [ Time Frame: Baseline and Week 8 ]

6.  Secondary:

Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8   [ Time Frame: Week 8 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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