Trial Outcomes & Findings for Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis (NCT NCT01012713)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

12 weeks

Results posted on

2015-06-18

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	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.
Overall Study Lack of Efficacy	3

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

Baseline characteristics by cohort
Measure	Open-Label Treatment n=30 Participants 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.
Age, Continuous	42.6 years STANDARD_DEVIATION 14.1 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	21 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants
Psoriasis Area and Severity Index	12.7 units on a scale STANDARD_DEVIATION 3.5 • n=93 Participants

Timeframe: 12 weeks

Outcome measures
Measure	Open-Label Treatment n=30 Participants 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.
The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.	83 percent Interval 65.0 to 94.0

Timeframe: 8 weeks

Outcome measures
Measure	Open-Label Treatment n=30 Participants 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.
The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8. Week 8	72 percent Interval 50.0 to 85.0
The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8. Week 4	45 percent Interval 31.0 to 52.0

Timeframe: 12 weeks

Outcome measures
Measure	Open-Label Treatment n=30 Participants 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.
A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.	45 percent Interval 27.0 to 62.0

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Open-Label Treatment n=30 participants at risk 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.
Skin and subcutaneous tissue disorders Phototoxicity	16.7% 5/30 • Number of events 5

University of California San Francisco

Phone: 4154764701