This is a multicenter study of subjects with mild to moderate psoriasis. Subjects will apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites). Biopsies of one target plaque will be collected at baseline (at least 7 days prior to first study treatment on Day 1) and at Days 29 and 64, with a 7-day interval between biopsy at Day 29 and commencement of application of application of active PH-10 on Day 36. Study data from each subject will serve as an internal control (i.e., assessment at baseline and at the end of application of PH-10 vehicle) for assessment of clinical and cellular response to active investigational agent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Subjects will apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites).
International Dermatology Research
Miami, Florida, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
DermResearch Inc.
Austin, Texas, United States
Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application
Time frame: 28 days
Psoriasis Severity Index (PSI) changes from pre-treatment
Time frame: 28 days
Plaque Response changes from Day 1 pre-treatment
Time frame: 28 days
Pruritus Self-Assessment score changes from Day 1 pre-treatment
Time frame: 28 days
Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque
Time frame: 28 days
Incidence of adverse experiences
Time frame: 28 days
Incidence of adverse changes in clinical laboratory tests
Time frame: 28 days
Incidence of adverse changes in weight or vital signs
Time frame: 28 days
Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.