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The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs and symptoms following the application of FB-401 in patients 2 years or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will be assessed by assessment of the skin and patient reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FB-401 | Experimental | FB-401 applied topically for 16 weeks. |
|
| Placebo | Placebo Comparator | Placebo applied topically for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB-401 | Biological | Topical application |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| EASI 50 | The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Includes percent change in EASI | Percent change in EASI score is measured from baseline to Week 16 | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First OC Dermatology | Fountain Valley | California | 92708 | United States | ||
| Center for Dermatology Clinical Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29720571 | Background | Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608. |
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| Biological |
Vehicle |
|
| Fremont |
| California |
| 94538 |
| United States |
| Multi-Specialty Research Associates, Inc. | Lake City | Florida | 32055 | United States |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | United States |
| DS Research | Clarksville | Indiana | 47129 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| DS Research | Louisville | Kentucky | 40241 | United States |
| Lawrence J. Green MD LLC | Rockville | Maryland | 20850 | United States |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | United States |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68516 | United States |
| Dermatology Consulting Services, PLLC | High Point | North Carolina | 27262 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| KGL Skin Study Center LLC | Newtown Square | Pennsylvania | 19073 | United States |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 9, 2023 | Nov 28, 2023 | 9 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| D004485 | Eczema |
| D012871 | Skin Diseases |
| D017443 | Skin Diseases, Eczematous |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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