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 phase 2 efficacy and safety study will assess topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
International Dermatology Research
Miami, Florida, United States
Mount Sinai School of Medicine
New York, New York, 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
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