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Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)

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ClinicalTrials.gov Identifier: NCT00608777
Recruitment Status : Terminated (Withdrawal of marketing autorization of efalizumab by the EMEA.)
First Posted : February 6, 2008
Results First Posted : April 3, 2012
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Plaque Psoriasis
Intervention: Drug: Calcipotriene/betamethasone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from January 2008 through December 2008. Subjects recruited from physician data base.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects experiencing mild localized breakthrough associated with Raptiva use were recruited.

Reporting Groups
  Description
Open Label Taclonex No text entered.

Participant Flow:   Overall Study
    Open Label Taclonex
STARTED   6 
COMPLETED   6 
NOT COMPLETED   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Open Label Taclonex No text entered.

Baseline Measures
   Open Label Taclonex 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   1 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   2 
Male   4 
Region of Enrollment 
[Units: Participants]
 
United States   6 


  Outcome Measures

1.  Primary:   The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2   [ Time Frame: week 2 ]


  Serious Adverse Events


  Other Adverse Events


  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
Study terminated due to withdrawal of Raptiva from the market. Study specifically designed to address a side effect associated with the administration of Raptiva. Therefore no data analysis completed for this study and no measuremnet of outcomes.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Leon Kircik, M.D.
Organization: DermResearch, PLLC
phone: 502-5451-9000
e-mail: wedoderm@yahoo.com


Publications:

Responsible Party: Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT00608777     History of Changes
Other Study ID Numbers: ACD4311s
First Submitted: January 23, 2008
First Posted: February 6, 2008
Results First Submitted: March 5, 2012
Results First Posted: April 3, 2012
Last Update Posted: August 10, 2012