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This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDI-192 Foam, 0.1% | Experimental | topical foam, 0.1% concentration, twice daily |
|
| PDI-192 Foam, 0.15% | Experimental | topical foam, 0.15% concentration, twice daily |
|
| Vehicle Foam | Placebo Comparator | topical foam, 0% concentration, twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDI-192 | Drug |
| ||
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| "Treatment Success" based on change in Investigator's Global Assessment (IGA) | Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe. | Baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pruritis Severity at Day 29 | Change from Baseline in the severity of pruritus (itching) at Day 29. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe. | Baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eczema Area and Severity Index (EASI) Score | Percent change from Baseline in EASI scores at Day 29. EASI excludes non-key signs of eczema (such as xerosis and scaling, oozing and crusting), and subjective parameters (such as pruritus and sleep loss) in order to focus the index on key disease signs and to avoid mixing objective parameters with subjective symptoms. EASI scores range from 0 (least severe) to 72 (most severe). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syd Dromgoole, PhD | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD - Rady Children's Hospital | San Diego | California | United States | |||
| Northwestern University |
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| Drug |
|
| Baseline and Day 29 |
| Change in Body Surface Area (BSA) Affected | Percent change from Baseline in the percent BSA affected by disease at Days 8, 15 and 29. | Baseline, Days 8, 15 and 29 |
| Change in Clinical Signs of Atopic Dermatitis (AD) | Change from Baseline in severity of erythema, induration/papulation, excoriation, lichenification and oozing/crusting at Days 8, 15, and 29. All clinical signs are evaluated on a 4-point ordinal scale from 0 (none) to 3 (severe). | Baseline and Days 8, 15 and 29 |
| Change in Pruritis Severity at Days 8 and 15 | Change from Baseline in the severity of pruritus (itching) at Days 8 and 15. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe. | Baseline and Days 8 and 15 |
| Subject Assessment of Improvement in Atopic Dermatitis | Subject global assessment of improvement in AD at Day 29, based on a 5-point ordinal scale from 1 (excellent improvement) to 5 (worse). | Day 29 |
| Chicago |
| Illinois |
| United States |
| Sneeze, Wheeze & Itch Associates, LLC | Normal | Illinois | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | United States |
| Dermatology Consulting Services | High Point | North Carolina | United States |
| DermResearch, Inc. | Austin | Texas | United States |
| UT Houston Health Science Center | Houston | Texas | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | United States |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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