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

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ClinicalTrials.gov Identifier: NCT01235728
Recruitment Status : Completed
First Posted : November 5, 2010
Results First Posted : June 11, 2014
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, 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
Enrollment 24

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4 Treatment Sequence 5 Treatment Sequence 6 Treatment Sequence 7 Treatment Sequence 8
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
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
Reason Not Completed
Protocol Violation             0             0             0             1             0             0             0             0
Arm/Group Title MK-0873
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
43.3
(30 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
7
  29.2%
Male
17
  70.8%
1.Primary Outcome
Title 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
Hide Description Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.
Time Frame Baseline and Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29.
Arm/Group Title MK-0873 MK-0873 Vehicle
Hide Arm/Group Description:
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 MK-0873 was evaluated.
Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
Overall Number of Participants Analyzed 23 23
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
23 23
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-47.37
(-56.87 to -37.86)
-42.71
(-52.21 to -33.22)
2.Secondary Outcome
Title Least Squares Mean Percent Change From Baseline (Predose Day 1) of TLS Score for Lesions Treated With MK-0873 and Lesions Treated With Calcitriol
Hide Description Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.
Time Frame Baseline and Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29
Arm/Group Title Calcitriol 0.0003% MK-0873
Hide Arm/Group Description:
Participants were randomly assigned to receive calcitriol 0.0003% (3mg/g) BID for 28 days on upper or lower lesion C or D and MK-0873 on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
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 MK-0873 was evaluated.
Overall Number of Participants Analyzed 23 23
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
23 23
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-57.24
(-66.82 to -47.67)
-47.89
(-57.39 to -38.40)
3.Secondary Outcome
Title Mean Maximum Plasma Concentrations at Trough of Day 8, 15, 22, and 29 Following Topical Administration of MK-0873 to Psoriatic Patients
Hide Description Plasma samples were collected at 12 hours post-dose on Days 8, 15, 22, and 28 to evaluate the mean maximum plasma concentration at trough of MK-0873.
Time Frame Day 8, 15, 22, 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received treatment, had no major protocol violations, and had MK-0873 plasma trough values available for the Day 8, 15, 22, and 28 treatment.
Arm/Group Title MK-0873
Hide Arm/Group Description:
Participants were randomized to receive MK- 0873 on upper or lower lesion A or B and MK-0873 Vehicle on the opposing lesion B or A, and MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: nM
3.6  (3.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK-0873
Hide Arm/Group Description 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.
All-Cause Mortality
MK-0873
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-0873
Affected / at Risk (%) # Events
Total   0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-0873
Affected / at Risk (%) # Events
Total   8/24 (33.33%)    
Infections and infestations   
Nasopharyngitis  1  3/24 (12.50%)  3
Nervous system disorders   
Headache  1  3/24 (12.50%)  3
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal Pain  1  3/24 (12.50%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01235728     History of Changes
Other Study ID Numbers: 0873-022
First Submitted: November 4, 2010
First Posted: November 5, 2010
Results First Submitted: May 13, 2014
Results First Posted: June 11, 2014
Last Update Posted: April 7, 2017