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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PH-10 Treatment (High Dose Cohort) | Experimental |
| |
| PH-10 Treatment (Mid Dose Cohort) | Experimental |
| |
| PH-10 Treatment (Low Dose Cohort) | Experimental |
| |
| Vehicle Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PH-10 (0.002% Rose Bengal) | Drug | PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Wachter, Ph.D. | Provectus Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Specialists, Inc. | Oceanside | California | 92056 | United States | ||
| International Dermatology Research |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012395 | Rose Bengal |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| PH-10 (0.005% Rose Bengal) | Drug | PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis. |
|
| PH-10 (0.01% Rose Bengal) | Drug | PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis. |
|
| Vehicle | Drug | PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis. |
|
| Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment. |
| 8 weeks |
| Miami |
| Florida |
| 33144 |
| United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27602 | United States |
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |