A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01235728
First received: November 4, 2010
Last updated: May 13, 2014
Last verified: May 2014
Results First Received: May 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Psoriasis
Plaque Psoriasis
Interventions: Drug: MK-0873 2% Cream
Drug: MK-0873 vehicle (placebo) Cream
Drug: Calcitriol Cream

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Sequence 1 Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
Treatment Sequence 2 Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
Treatment Sequence 3 Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
Treatment Sequence 4 Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-873 on upper lesion D.
Treatment Sequence 5 Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
Treatment Sequence 6 Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
Treatment Sequence 7 Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
Treatment Sequence 8 Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.

Participant Flow:   Overall Study
    Treatment Sequence 1     Treatment Sequence 2     Treatment Sequence 3     Treatment Sequence 4     Treatment Sequence 5     Treatment Sequence 6     Treatment Sequence 7     Treatment Sequence 8  
STARTED     3     3     3     3     3     3     3     3  
COMPLETED     3     3     3     2     3     3     3     3  
NOT COMPLETED     0     0     0     1     0     0     0     0  
Protocol Violation                 0                 0                 0                 1                 0                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
MK-0873 Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.

Baseline Measures
    MK-0873  
Number of Participants  
[units: participants]
  24  
Age  
[units: Years]
Mean ( Full Range )
  43.3  
  ( 30 to 59 )  
Gender  
[units: Participants]
 
Female     7  
Male     17  



  Outcome Measures
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1.  Primary:   Least Squares Mean Percent Change From Baseline (Predose Day 1) of Target Lesion Severity (TLS) Score for Lesions Treated With MK-0873 and Lesions Treated With MK-0873 Vehicle   [ Time Frame: Baseline and Day 29 ]

2.  Secondary:   Least Squares Mean Percent Change From Baseline (Predose Day 1) of TLS Score for Lesions Treated With MK-0873 and Lesions Treated With Calcitriol   [ Time Frame: Baseline and Day 29 ]

3.  Secondary:   Mean Maximum Plasma Concentrations at Trough of Day 8, 15, 22, and 29 Following Topical Administration of MK-0873 to Psoriatic Patients   [ Time Frame: Day 8, 15, 22, 29 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01235728     History of Changes
Other Study ID Numbers: 0873-022
Study First Received: November 4, 2010
Results First Received: May 13, 2014
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration