Subject Preference for Scalp Psoriasis Treatment

This study has been completed.

Study NCT00438399 Information provided by Galderma

First Received on February 21, 2007. Last Updated on November 21, 2011 History of Changes

Results First Received: June 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Scalp Psoriasis
Interventions:	Drug: C. propionate - Corticosteroid 1 Drug: C. propionate- Corticosteroid 2 Drug: C. propionate -Corticosteroid 3 Drug: Corticosteroid 1- C. propionate Drug: Corticosteroid 2 - C. propionate Drug: Corticosteroid 3 - C. propionate

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
Patients were enrolled in 18 centres in Italy, Spain, United Kingdom and Germany between 19 February 2007 until 22 January 2008

Pre-Assignment Details

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

Reporting Groups

	Description
C. Propionate-Wash Out-Corticosteroid 1	Clobetasol propionate Shampoo first, then Corticosteroid 1
Corticosteroid 1-Wash Out-C. Propionate	Corticosteroid 1 first then Clobetasol propionate Shampoo
C. Propionate-Wash Out-Corticosteroid 2	Clobetasol propionate Shampoo first, then Corticosteroid 2
Corticosteroid 2-Wash Out-C. Propionate	Corticosteroid 2 first, then Clobetasol propionate shampoo
C. Propionate -Wash Out-Corticosteroid 3	Clobetasol propionate shampoo first then Corticosteroid 3
Corticosteroid 3-Wash Out-C. Propionate	Corticosteroid 3 first, then Clobetasol propionate

Participant Flow: Overall Study

	C. Propionate-Wash Out-Corticosteroid 1	Corticosteroid 1-Wash Out-C. Propionate	C. Propionate-Wash Out-Corticosteroid 2	Corticosteroid 2-Wash Out-C. Propionate	C. Propionate -Wash Out-Corticosteroid 3	Corticosteroid 3-Wash Out-C. Propionate
STARTED	38	40	35	36	33	37
TREATED & ANALYZED	30	32	28	32	30	31
COMPLETED	30	32	28	32	30	31
NOT COMPLETED	8	8	7	4	3	6
Lost to Follow-up	2	2	1	1	1	1
Adverse Event	0	0	1	1	0	1
Withdrawal by Subject	5	6	3	2	2	2
Protocol Violation	0	0	1	0	0	1
Subje stopped study	0	0	1	0	0	0
Pregnancy	0	0	0	0	0	1
Patien stopped study at visit 4 by error	1	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
C. Propionate Compared to Corticosteroid 1	C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
C. Propionate Compared to Corticosteroid 2	C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
C. Propionate Compared to Corticosteroid 3	C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily

Baseline Measures

	C. Propionate Compared to Corticosteroid 1	C. Propionate Compared to Corticosteroid 2	C. Propionate Compared to Corticosteroid 3	Total
Number of Participants [units: participants]	78	71	70	219
Age [units: participants]
<=18 years	0	1	0	1
Between 18 and 65 years	58	55	57	170
>=65 years	20	15	13	48
Age [units: years] Mean ± Standard Deviation	50.8 ± 15.9	49.2 ± 14.9	47.8 ± 16.2	49.3 ± 15.6
Gender [units: participants]
Female	45	32	36	113
Male	33	39	34	106
Region of Enrollment [units: participants]
Italy	16	16	16	48
United Kingdom	17	15	11	43
Spain	9	5	9	23
Germany	36	35	34	105

Outcome Measures

1. Primary:

Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator [ Time Frame: End of period II (up to 16 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: Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor to review and approval at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.

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: Farzaneh SIDOU Clinical Project Manager
Organization: Galderma
phone: 00 33 4 93 95 70 70 ext 70 51
e-mail: farzaneh.sidou@galderma.com

No publications provided

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT00438399 History of Changes
Other Study ID Numbers:	RD.03.SPR.29064, 2006-003073-27
Study First Received:	February 21, 2007
Results First Received:	June 22, 2011
Last Updated:	November 21, 2011
Health Authority:	Italy: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines