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

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ClinicalTrials.gov Identifier: NCT01012713
Recruitment Status : Completed
First Posted : November 13, 2009
Results First Posted : June 18, 2015
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Stable Plaque Psoriasis
Interventions Drug: Clobex Spray
Drug: Vectical Ointment
Procedure: Excimer Laser
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-Label Treatment
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 30
Completed 27
Not Completed 3
Reason Not Completed
Lack of Efficacy             3
Arm/Group Title Open-Label Treatment
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
42.6  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
9
  30.0%
Male
21
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
Psoriasis Area and Severity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants
12.7  (3.5)
[1]
Measure Description: 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.
1.Primary Outcome
Title The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
83
(65 to 94)
2.Secondary Outcome
Title The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Treatment
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
Week 8
72
(50 to 85)
Week 4
45
(31 to 52)
3.Secondary Outcome
Title A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Treatment
Hide Arm/Group Description:

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 a 75% reduction in Psoriasis Area and Severity Index.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
45
(27 to 62)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-Label Treatment
Hide Arm/Group Description

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.

All-Cause Mortality
Open-Label Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label Treatment
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open-Label Treatment
Affected / at Risk (%) # Events
Total   5/30 (16.67%)    
Skin and subcutaneous tissue disorders   
Phototoxicity [1]  5/30 (16.67%)  5
[1]
Minor burning, redness or blistering from laser treatment
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
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01012713     History of Changes
Other Study ID Numbers: Perfect Storm
First Submitted: November 10, 2009
First Posted: November 13, 2009
Results First Submitted: May 28, 2015
Results First Posted: June 18, 2015
Last Update Posted: June 18, 2015