Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01012713
First received: November 10, 2009
Last updated: June 16, 2015
Last verified: June 2015
Results First Received: May 28, 2015  
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: Chronic Stable Plaque Psoriasis
Interventions: Drug: Clobex Spray
Drug: Vectical Ointment
Procedure: Excimer Laser

  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
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Reporting Groups
  Description
Open-Label Treatment

All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser

Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12

Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12

Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in the Psoriasis Area and Severity Index thereafter.


Participant Flow:   Overall Study
    Open-Label Treatment  
STARTED     30  
COMPLETED     27  
NOT COMPLETED     3  
Lack of Efficacy                 3  



  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
Open-Label Treatment

All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser

Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12

Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12

Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter.


Baseline Measures
    Open-Label Treatment  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean (Standard Deviation)
  42.6  (14.1)  
Gender  
[units: participants]
 
Female     9  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     30  
Psoriasis Area and Severity Index [1]
[units: units on a scale]
Mean (Standard Deviation)
  12.7  (3.5)  
[1] Psoriasis Area and Severity Index measures the severity of psoriasis on a scale of 0 (no evidence of psoriasis) to 72 (worst possible psoriasis). The score is based on the redness, scaling, thickness and amount of body surface area affected by psoriasis.



  Outcome Measures
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1.  Primary:   The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.   [ Time Frame: 12 weeks ]

2.  Secondary:   The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.   [ Time Frame: 8 weeks ]

3.  Secondary:   A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.   [ Time Frame: 12 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. John Koo
Organization: University of California San Francisco
phone: 4154764701
e-mail: john.koo@ucsfmedctr.org


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01012713     History of Changes
Other Study ID Numbers: Perfect Storm
Study First Received: November 10, 2009
Results First Received: May 28, 2015
Last Updated: June 16, 2015
Health Authority: United States: Institutional Review Board