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NCT01012713 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis
A Phase 4 study of Chronic Stable Plaque Psoriasis, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01012713 is a Phase 4 study of Chronic Stable Plaque Psoriasis that has completed, run by University of California, San Francisco. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01012713, a Phase 4 study of Chronic Stable Plaque Psoriasis, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 12-week, open-label, pilot trial evaluating the efficacy and safety of the combination of Clobex® spray with excimer laser therapy as the initial treatment of generalized plaque psoriasis, followed by maintenance therapy with topical Vectical. The study will be conducted in three distinct periods, namely Period A, Period B, and Period C, each of 4 weeks duration. During Period A (weeks 1 through 4), patients will use Clobex® spray twice daily along with excimer laser treatments twice weekly with the Photomedex XTRAC® Velocity machine. The goal of Period A is to achieve Psoriasis Area Severity Index (PASI) 75 in 100% of patients within four weeks. During Period B (weeks 5 through 8), patients would be treated with topical Vectical® twice daily. Thus, there is a steroid-free interval during which patients will not be using Clobex® spray. The goal of Period B is to maintain the patient's response using only non-steroid options. During Period C of the study, patients will use Clobex® spray BID and Vectical® BID. Period C (weeks 9 through 12) will be a "booster" period in which the goal is to see if 100% of patients can achieve Psoriasis Area Severity Index (PASI) 90-100. Regarding excimer laser therapy: all patients will be receiving excimer laser therapy twice weekly for the first 6 weeks of the study (up to the halfway point) which is 12 excimer laser treatments. At that point, only those patients achieving \<Psoriasis Area Severity Index (PASI)75 response will continue to receive twice weekly excimer laser treatments for the remaining 6 weeks of the study.
Conditions Studied
Interventions
- DRUG Clobex Spray
- DRUG Vectical Ointment
- PROCEDURE Excimer Laser
Study Locations (1)
California
- UCSF Psoriasis and Skin Treatment Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01012713
The ClinicalTrials.gov registry entry for NCT01012713 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Stable Plaque Psoriasis appearing as the primary indexed condition, and to 3 interventions - of which Clobex Spray is the first listed.
NCT01012713 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01012713 about?
NCT01012713 is a clinical study titled "Safety and Efficacy Study of Combination Treatment With Excimer Laser, Clobex Spray, and Vectical Ointment in the Treatment of Psoriasis". This is a 12-week, open-label, pilot trial evaluating the efficacy and safety of the combination of Clobex® spray with excimer laser therapy as the initial treatment of generalized plaque psoriasis, followed by maintenance therapy with topical Vectical. The study will be conducted in three distinct ...
What is the current status of trial NCT01012713?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2010-06. Estimated completion is 2014-12.
What conditions does trial NCT01012713 study?
This clinical trial studies the following conditions: Chronic Stable Plaque Psoriasis.
What interventions are being tested in trial NCT01012713?
The interventions under investigation include: Clobex Spray (DRUG), Vectical Ointment (DRUG), Excimer Laser (PROCEDURE).
Who is sponsoring clinical trial NCT01012713?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01012713 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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