Randomized Study of PH-10 for Psoriasis
Phase 2
Completed
- Conditions
- Psoriasis
- Interventions
- Drug: PH-10 (0.002% Rose Bengal)Drug: VehicleDrug: PH-10 (0.01% Rose Bengal)Drug: PH-10 (0.005% Rose Bengal)
- Registration Number
- NCT01247818
- Lead Sponsor
- Provectus Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
Inclusion Criteria
- Men or women, age 18 or older.
- Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
- Fitzpatrick skin type I-VI.
- Written informed consent by the subject or legal guardian.
Exclusion Criteria
- Female subjects of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
- Subjects who have received psoralen plus ultraviolet A (PUVA) therapy or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
- Subjects who have received ultraviolet B (UVB) light therapy within 14 days of study initiation.
- Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
- Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
- Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
- Subjects who have participated in a clinical research study within 28 days of study initiation.
- Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- Subjects with clinical conditions that, in the opinion of the Investigator may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PH-10 Treatment (Low Dose Cohort) PH-10 (0.002% Rose Bengal) - Vehicle Control Vehicle - PH-10 Treatment (High Dose Cohort) PH-10 (0.01% Rose Bengal) - PH-10 Treatment (Mid Dose Cohort) PH-10 (0.005% Rose Bengal) -
- Primary Outcome Measures
Name Time Method The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). 8 weeks 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. 28 days
- Secondary Outcome Measures
Name Time Method Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment. 8 weeks Plaque Response score changes at each visit from Day 1 pre-treatment. 8 weeks Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment. 8 weeks
Trial Locations
- Locations (4)
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
International Dermatology Research
🇺🇸Miami, Florida, United States
Dermatology Specialists, Inc.
🇺🇸Oceanside, California, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States