Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

This study has been completed.

Study NCT00881868 Information provided by Galderma Laboratories, L.P.

First Received on April 13, 2009. Last Updated on January 7, 2011 History of Changes

Results First Received: December 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Scalp Psoriasis
Interventions:	Drug: clobetasol propionate spray 0.05% Drug: Vehicle spray

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
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.

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

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

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

Reporting Groups

	Description
Clobex Spray	No text entered.
Vehicle Spray	No text entered.

Participant Flow: Overall Study

	Clobex Spray	Vehicle Spray
STARTED	41	40
COMPLETED	33	38
NOT COMPLETED	8	2
Adverse Event	0	1
Lost to Follow-up	2	1
Physician Decision	4	0
Protocol Violation	2	0

Baseline Characteristics

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Reporting Groups

	Description
Clobex Spray	No text entered.
Vehicle Spray	No text entered.

Baseline Measures

	Clobex Spray	Vehicle Spray	Total
Number of Participants [units: participants]	41	40	81
Age [units: years] Mean ± Standard Deviation	46.0 ± 15.41	41.3 ± 13.72	43.7 ± 14.69
Gender [units: participants]
Female	25	24	49
Male	16	16	32

Outcome Measures

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1. 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) [ Time Frame: baseline to week 4 ]

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2. Secondary:

Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4 [ Time Frame: baseline to week 4 ]

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3. Secondary:

Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4 [ Time Frame: baseline to week 4 ]

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4. Secondary:

Number of Participants in Each Category of Pruritus at Baseline and Week 4 [ Time Frame: baseline to week 4 ]

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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: 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.

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
No text entered.

Results Point of Contact:

Name/Title: Ronald W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
phone: 817-961-5358
e-mail: ron.gottschalk@galderma.com

No publications provided

Responsible Party:	Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00881868 History of Changes
Other Study ID Numbers:	US10118
Study First Received:	April 13, 2009
Results First Received:	December 16, 2010
Last Updated:	January 7, 2011
Health Authority:	United States: Food and Drug Administration