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

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01139580

First received: June 6, 2010

Last updated: February 23, 2012

Last verified: February 2012

History of Changes

Results First Received: August 18, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Psoriasis
Interventions:	Drug: Calcipotriene Foam Drug: Vehicle Foam

Participant Flow

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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

Baseline Characteristics

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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
Number of Participants [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]
Female	69	76	145
Male	112	106	218
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

Outcome Measures

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01139580 History of Changes
Other Study ID Numbers:	114743, U0267-303
Study First Received:	June 6, 2010
Results First Received:	August 18, 2011
Last Updated:	February 23, 2012
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

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