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The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PR022 topical gel, 0.05% | Experimental | Applied twice daily for 28 days |
|
| PR022 topical gel, 0.1% | Experimental | Applied twice daily for 28 days |
|
| PR022 topical gel vehicle | Placebo Comparator | Applied twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PR022 | Drug | Topical Gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI) | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of "Clear" (0) or "Almost Clear" (1) with a minimum 2-grade improvement at Day 29 | 29 Days | |
| Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum IgE titer and TARC concentration from Baseline to Day 29 | 29 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie Crossley | Contact | 4843212700 | Valerie@realmtx.com | |
| Kathy Goin | Contact | kgoin@realmtx.com |
| Name | Affiliation | Role |
|---|---|---|
| Christian Peters, MD, PhD | Realm | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Principal Investigator | Recruiting | Philadelphia | Pennsylvania | 19148 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 27, 2019 | |
| Reset | Nov 15, 2019 | |
| Release | Jan 17, 2020 | |
| Reset | Jan 28, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 27, 2019 | Nov 15, 2019 | |||
| Jan 17, 2020 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| 29 Days |
| Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29 | 29 Days |
| Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29 | 29 Days |
| Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD | 29 Days |
| Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD) | 29 Days |
| Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS) | 29 Days |
| Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale | 29 days |
| Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI) | 29 days |
| Frequency counts and percentages of DLQI scores (scored 0 to 3) at Baseline and Day 29, as well as shift in DLQI scores from Baseline to Day 29 | 29 Days |
| Jan 28, 2020 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |