Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

GlaxoSmithKline ( Stiefel, a GSK Company )

ClinicalTrials.gov Identifier:

NCT00689481

First received: May 29, 2008

Last updated: April 5, 2012

Last verified: April 2012

History of Changes

Results First Received: November 5, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Psoriasis
Interventions:	Drug: U0267 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 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Vehicle Foam	Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

Participant Flow: Overall Study

	Calcipotriene Foam	Vehicle Foam
STARTED	214	109
COMPLETED	190	95
NOT COMPLETED	24	14
Adverse Event	7	1
Lost to Follow-up	4	3
Lack of Efficacy	4	3
Non-compliance with study treatment	1	1
Withdrawal by Subject	8	4
Excluded medication started during study	0	1
Subject early term, left on vacation	0	1

Baseline Characteristics

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Reporting Groups

	Description
Calcipotriene Foam	Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Vehicle Foam	Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Total	Total of all reporting groups

Baseline Measures

	Calcipotriene Foam	Vehicle Foam	Total
Number of Participants [units: participants]	214	109	323
Age [units: years] Mean ± Standard Deviation	47.9 ± 14.2	47.5 ± 16.9	47.8 ± 15.2
Age, Customized [units: participants]
12 to < 18 years	2	3	5
18 to < 65 years	185	88	273
> 65 years	27	18	45
Gender [units: participants]
Female	108	59	167
Male	106	50	156
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	0	0	0
Asian	10	3	13
Black	5	4	9
Mulitracial	4	2	6
Native Hawaiian or Other Pacific Islander	1	1	2
White	194	99	293
Disease Characteristic - Erythema ^[1] [units: participants]
Light red coloration	52	30	82
Moderate red coloration	158	76	234
Bright red coloration	4	3	7
Disease Characteristic - Scaling ^[2] [units: participants]
Minimal	1	0	1
Mild	65	33	98
Moderate	145	76	221
Marked	2	0	2
Severe	1	0	1
Disease Characteristic - Plaque Thickness ^[3] [units: participants]
Possible but difficult to ascertain	1	1	2
Slight but definite elevation	66	41	107
Moderate elevation	144	66	210
Marked elevation	2	1	3
Very marked elevation	1	0	1
Disease Characteristic - Target Lesion Location ^[4] [units: participants]
Arm	53	27	80
Leg	129	55	184
Trunk	32	27	59
Disease Characteristic - Investigator Static Global Assesssment (ISGA) ^[5] [units: participants]
Mild	56	31	87
Moderate	158	78	236
Disease Characteristic - Subject's Global Assessment ^[6] [units: participants]
Almost clear	2	2	4
Mild	18	9	27
Moderate	62	26	88
Very noticeable	96	55	151
Severe	36	17	53
Disease Characteristic - Percent BSA (extent of psoriasis) ^[7] [units: percentage] Mean ± Standard Deviation	6.3 ± 4.7	6.4 ± 5.2	6.4 ± 4.9

[1]	Disease characteristics of Erythema at baseline
[2]	Disease characteristics of Scaling at baseline
[3]	Disease characteristics of Plaque Thickness at baseline
[4]	Disease characteristics of Target Lesion Location at baseline
[5]	Disease characteristics of ISGA at baseline
[6]	Disease characteristics of Subject's Global Assessment at baseline
[7]	Disease characteristics of Percent of BSA (extent of psoriasis) at baseline

Outcome Measures

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1. Primary:

Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment [ Time Frame: 8 weeks ]

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2. Secondary:

Number of Subjects 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: 8 Weeks ]

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3. Secondary:

Number of Subjects 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: 8 Weeks ]

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4. Secondary:

Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 [ Time Frame: 8 Weeks ]

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5. Secondary:

Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 [ Time Frame: 8 Weeks ]

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6. Secondary:

Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) [ Time Frame: 8 Weeks ]

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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 by GlaxoSmithKline

Publications automatically indexed to this study:

Feldman SR, Matheson R, Bruce S, Grande K, Markowitz O, Kempers S, Brundage T, Wyres M; U0267-301 & 302 Study Investigators. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials. Am J Clin Dermatol. 2012 Aug 1;13(4):261-71. doi: 10.2165/11630710-000000000-00000.

Responsible Party:	GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:	NCT00689481 History of Changes
Other Study ID Numbers:	114742, U0267-302
Study First Received:	May 29, 2008
Results First Received:	November 5, 2010
Last Updated:	April 5, 2012
Health Authority:	United States: Food and Drug Administration

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