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PH-10 is a formulation of rose bengal disodium (RB) for topical administration to the skin. PH-10 is capable of undergoing photochemical reactions when activated by ambient light. This phase 2 study will assess whether topical PH-10 applied once daily to mild, moderate or severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of the skin when activated by ambient light.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PH-10 treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PH-10 | Drug | PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is "Treatment Success," a static endpoint defined as a score of 0 to 1 at Day 28 (at the end of the study treatment period) by the Investigator's Global Assessment (IGA) scoring system for atopic dermatitis status. | 28 days | |
| Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment. | 8 weeks | |
| Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs 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 |
|---|---|---|
| Alicia Barba, MD | International Dermatology Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Dermatology Research | Miami | Florida | 33144 | United States | ||
| Mount Sinai School of Medicine |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 5, 2021 | |
| Reset | Dec 1, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 5, 2021 | Dec 1, 2021 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment. | 8 weeks |
| Adverse change in clinical laboratory tests (CBC and CMP). | 8 weeks |
| Adverse change in vital signs (BP, pulse, temperature). | 8 weeks |
| New York |
| New York |
| 10029 |
| United States |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |