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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 6
Recruitment Details Recruitment from January 2008 through December 2008. Subjects recruited from physician data base.
Pre-assignment Details Subjects experiencing mild localized breakthrough associated with Raptiva use were recruited.
Arm/Group Title Open Label Taclonex
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Open Label Taclonex
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  83.3%
>=65 years
1
  16.7%
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  83.3%
>=65 years
1
  16.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2
Hide Description [Not Specified]
Time Frame week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Taclonex
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Open Label
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open Label
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label
Affected / at Risk (%)
Total   0/6 (0.00%) 
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.
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
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