A total of 226 subjects have been treated with PH-10 in Phase 1 or Phase 2 clinical trials.
Phase 2 Mechanism of Action Trial
In September 2015, patient accrual was completed.
Patient enrollment began in March 2015.
In January 2015, a Phase 2 study of PH-10 aqueous hydrogel for the treatment of plaque psoriasis was initiated.This multicenter study will assess the clinical and cellular response to PH-10's active investigational agent in an estimated 30 subjects.
Primary Outcome Measures:
Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application
Secondary Outcome Measures
Psoriasis Severity Index (PSI) changes from pre-treatment
Plaque Response changes from Day 1 pre-treatment
Pruritus Self-Assessment score changes from Day 1 pre-treatment
Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque
Incidence of adverse experiences
Incidence of adverse changes in clinical laboratory tests
Incidence of adverse changes in weight or vital signs
Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin