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A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mount Sinai School of Medicine
New York, New York, United States
Start Date
November 1, 2007
Primary Completion Date
September 1, 2008
Completion Date
September 1, 2008
Last Updated
December 16, 2021
6
ACTUAL participants
PH-10 (rose bengal disodium 0.001%)
DRUG
PH-10 (rose bengal disodium 0.001%)
DRUG
Control
DRUG
Lead Sponsor
Provectus Pharmaceuticals
NCT07116967
NCT07250802
NCT07449702
Data Source & Attribution
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