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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PH-10 | Experimental | Active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Rose Bengal, 0.005% | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Severity Index (PSI) changes from pre-treatment | 28 days | |
| Plaque Response changes from Day 1 pre-treatment | 28 days | |
| Pruritus Self-Assessment score changes from Day 1 pre-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Wachter, Ph.D. | Provectus Biopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Dermatology Research | Miami | Florida | 33144 | United States | ||
| University of North Carolina School of Medicine |
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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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|
|
| 28 days |
| Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque | 28 days |
| Incidence of adverse experiences | 28 days |
| Incidence of adverse changes in clinical laboratory tests | 28 days |
| Incidence of adverse changes in weight or vital signs | 28 days |
| Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin | 28 days |
| Chapel Hill |
| North Carolina |
| 27516 |
| United States |
| DermResearch Inc. | Austin | Texas | 78759 | United States |
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |