PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
99
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Dermatology Specialists, Inc.
Oceanside, California, United States
International Dermatology Research
Miami, Florida, United States
Mount Sinai School of Medicine
New York, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
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.
Time frame: 28 days
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Time frame: 8 weeks
Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
Plaque Response score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.