In December 2010, a Phase 2c dose-randomized, vehicle-controlled study of PH-10 aqueous hydrogel for the treatment of plaque psoriasis was initiated. This multicenter study of an estimated 90 subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
- PH-10 (0.002% Rose Bengal)
- PH-10 (0.005% Rose Bengal)
- PH-10 (0.01% Rose Bengal)
Primary Outcome Measures:
- The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
- The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Secondary Outcome Measures
- Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
- Plaque Response score changes at each visit from Day 1 pre-treatment.
- Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.