PH-10 Mechanism of Action (Psoriasis)

Future Plans

  • 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

NEWSLETTER
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