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Sponsored by: |
Provectus Pharmaceuticals |
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Information provided by: | Provectus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00555646 |
This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control.
Subjects with at least three distinct, stable study plaque areas will receive the experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission is observed in a treatment plaque area then treatment of that area will be discontinued and the area assessed weekly. A third plaque area (control plaque area) will receive no drug or light treatment and serve as an internal control.
Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be followed for a total of 16 weeks to allow assessment of Durability of Response of treated lesions and comprehensive follow-up of adverse events.
Condition | Intervention | Phase |
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Plaque Psoriasis |
Drug: PH-10 (rose bengal disodium 0.001%) Drug: Control |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis |
Estimated Enrollment: | 25 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area.
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Drug: PH-10 (rose bengal disodium 0.001%)
PH-10 with 544 nm LED light illumination OR PH-10 with ambient light exposure
No treatment control.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Giselle Singer | (212) 241-3288 | Giselle.Singer@mssm.edu |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029 | |
Principal Investigator: Amir Larian, MD |
Principal Investigator: | Amir Larian, MD | Mount Sinai School of Medicine |
Responsible Party: | Provectus Pharmaceuticals, Inc. ( Eric Wachter, Ph.D./Vice President ) |
Study ID Numbers: | PH-10-PS-21 |
Study First Received: | November 7, 2007 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00555646 |
Health Authority: | United States: Food and Drug Administration |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |