Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds - Study Results - ClinicalTrials.gov

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Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds

This study has been completed.

Study NCT00640822 Information provided by LEO Pharma

First Received on March 18, 2008. Last Updated on January 12, 2011 History of Changes

Results First Received: November 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Psoriasis Vulgaris
Interventions:	Drug: Calcipotriol plus hydrocortisone ointment vehicle Drug: Tacalcitol Ointment Drug: Calcipotriol plus hydrocortisone ointment

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
Date of first subject visit was 5 Mar 2008. Date of last subject visit was 18 Jun 2009. Patients came from hospital outpatient clinics or private practice

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty-one subjects were not randomised. Most we screen failures or did not have the required extent of disease or withdrew before randomization

Reporting Groups

	Description
Calcipotriol Plus Hydrocortisone Ointment	Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
Tacalcitol Ointment	Tacalcitol once daily for up to 8 weeks
Calcipotriol Plus Hydrocortisone Ointment Vehicle	Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks

Participant Flow: Overall Study

	Calcipotriol Plus Hydrocortisone Ointment	Tacalcitol Ointment	Calcipotriol Plus Hydrocortisone Ointment Vehicle
STARTED	322	317	102
COMPLETED	279	258	77
NOT COMPLETED	43	59	25

Baseline Characteristics

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Reporting Groups

	Description
Calcipotriol Plus Hydrocortisone Ointment	Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
Tacalcitol Ointment	Tacalcitol once daily for up to 8 weeks
Calcipotriol Plus Hydrocortisone Ointment Vehicle	Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks

Baseline Measures

	Calcipotriol Plus Hydrocortisone Ointment	Tacalcitol Ointment	Calcipotriol Plus Hydrocortisone Ointment Vehicle	Total
Number of Participants [units: participants]	322	317	102	741
Age [units: years] Mean ± Standard Deviation	48 ± 15.5	49 ± 15.5	48.8 ± 14.2	48.5 ± 15.3
Gender [units: participants]
Female	126	136	41	303
Male	196	181	61	438
Region of Enrollment [units: participants]
France	95	83	38	216
Canada	131	129	37	297
United Kingdom	96	105	27	228

Outcome Measures

1. Primary:

Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8 [ Time Frame: Week 8 ]

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2. Secondary:

Overall Disease Severity of the Face According to the Investigator's Assessment [ Time Frame: Week 4 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Total Sign Score of the Face [ Time Frame: Week 8 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Severity Scores for Redness, Thickness and Scaliness of the Face [ Time Frame: Week 8 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment [ Time Frame: Week 8 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

6. Secondary:

Total Sign Score of the Intertriginous Areas [ Time Frame: Week 8 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

7. Secondary:

Patients With Relapse During the Study and Time to Relapse [ Time Frame: Week 8-16 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

8. Secondary:

Patients With Rebound During the Study [ Time Frame: Week 8-16 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

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 Company acknowledges the investigators’ right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.

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: Torsten Skov
Organization: LeoPharma
phone: +4520736294
e-mail: torsten.skov@leo-pharma.com

No publications provided

Responsible Party:	Kirsten L. Nørrelund, Principal Clinical Trial Manager, LEO Pharma A/S
ClinicalTrials.gov Identifier:	NCT00640822 History of Changes
Other Study ID Numbers:	LEO 80190-O22
Study First Received:	March 18, 2008
Results First Received:	November 23, 2010
Last Updated:	January 12, 2011
Health Authority:	Canada: Health Canada France: Afssaps - French Health Products Safety Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

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