Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

LEO Pharma

ClinicalTrials.gov Identifier:

NCT00817219

First received: January 5, 2009

Last updated: January 7, 2013

Last verified: January 2013

History of Changes

Results First Received: December 4, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Psoriasis Vulgaris
Intervention:	Drug: Calcipotriene plus betamethasone dipropionate 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
The study period was 15 July 2009 (date of first subject’s first screening visit) to 05 December 2011 (date of the last subject’s last on-treatment visit)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Before starting treatment there was a washout/screening phase lasting for 3 days to 6 weeks, depending on the prior use of excluded treatments.

Reporting Groups

	Description
TACLONEX Ointment	TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks

Participant Flow: Overall Study

	TACLONEX Ointment
STARTED	33
COMPLETED	33
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
TACLONEX Ointment	TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks

Baseline Measures

	TACLONEX Ointment
Number of Participants [units: participants]	33
Age [units: years] Mean ± Standard Deviation	14.6 ± 1.6
Gender [units: participants]
Female	17
Male	16

Outcome Measures

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1. Primary:

Adverse Drug Reactions [ Time Frame: Week 4 ]

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2. Primary:

Serum Cortisol Concentration of ≤18 Mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment [ Time Frame: Week 4 ]

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3. Primary:

Serum Cortisol Concentration of ≤18 Mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment [ Time Frame: Week 4 ]

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4. Primary:

Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment [ Time Frame: Baseline and 4 weeks ]

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5. Primary:

Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. [ Time Frame: Baseline and 4 Weeks ]

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6. Secondary:

“Controlled Disease”(i.e., “Clear” or “Almost Clear”) According to the Investigator’s Global Assessment of Disease Severity at Week 4. [ Time Frame: Week 4 ]

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7. Secondary:

“Controlled Disease”(i.e., “Clear” or “Very Mild”) According to the Patient’s Global Assessment of Disease Severity at Week 4. [ Time Frame: Week 4 ]

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8. Secondary:

Percentage Change in PASI From Baseline to Week 4. [ Time Frame: Baseline and 4 weeks ]

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9. Secondary:

PASI 75 at Week 4. [ Time Frame: 4 weeks ]

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10. Secondary:

PASI 50 at Week 4. [ Time Frame: 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: LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO 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: Malin Järnkrants
Organization: LEO Pharma A/S
phone: +45 7226 2990
e-mail: malin.jaernkrants@leo-pharma.com

No publications provided

Responsible Party:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00817219 History of Changes
Other Study ID Numbers:	MCB 0501 INT
Study First Received:	January 5, 2009
Results First Received:	December 4, 2012
Last Updated:	January 7, 2013
Health Authority:	United States: Food and Drug Administration

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