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This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Difamilast Ointment 1% | Experimental | A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difamilast | Drug | Difamilast Ointment 1% |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug | 52 week study period | |
| Proportion of subjects who discontinue due to an AE over the study period | 52-week study period |
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Important Inclusion Criteria:
Important Exclusion Criteria:
Subjects who have an AD flare (defined as rapid intensification of AD) within 28 days prior to Screening or Baseline (except for those previously enrolled in Study MEDI-MM36-301) or history of consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms.
Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD
Subjects with significant systemic or localized infection
Subjects with minimal/mild depression and suicidal ideation
Subjects using restricted medications, biologics and alternative therapies, or using investigational drug
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| Name | Affiliation | Role |
|---|---|---|
| Uma S Atmuri, MPharm MS | Acrotech Biopharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qualmedica Research, LLC | Birmingham | Alabama | 35205 | United States | ||
| AllerVie Health |
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| Birmingham |
| Alabama |
| 35244 |
| United States |
| Elite Clinical Studies, LLC | Phoenix | Arizona | 85018 | United States |
| NEA Baptist Clinic-Dermatology | Jonesboro | Arkansas | 72405 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Southern CA Dermatology Skin and Laser | Laguna Niguel | California | 92677 | United States |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Clinical Trials Research Institute | Thousand Oaks | California | 91320 | United States |
| Clarity Dermatology, LLC | Castle Rock | Colorado | 80109 | United States |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| TrueBlue Clinical Research | Brandon | Florida | 33511 | United States |
| Annexus Dermatology & Aethestics | DeLand | Florida | 32720 | United States |
| Accel Research - Edgewater Clinical Research Unit | Edgewater | Florida | 32132 | United States |
| Skin Care Research | Hollywood | Florida | 33021 | United States |
| Kirsch Dermatology | Naples | Florida | 34102 | United States |
| Tory Sullivan, MD PA | North Miami Beach | Florida | 33162 | United States |
| Pure Skin Dermatology & Aesthetics | Orlando | Florida | 32819 | United States |
| Nona Pediatrics | Orlando | Florida | 32829 | United States |
| Accel Research - Ormond Clinical Research Unit | Ormond Beach | Florida | 32174 | United States |
| Olympian Clinical Research | St. Petersburg | Florida | 33706 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | United States |
| DS Research | Clarksville | Indiana | 47129 | United States |
| Qualmedica Research, LLC | Evansville | Indiana | 47715 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| Options Research Group, LLC | West Lafayette | Indiana | 47906 | United States |
| Meridian Clinical Research | Overland Park | Kansas | 66210 | United States |
| Qualmedica Research, LLC | Bowling Green | Kentucky | 42101 | United States |
| DS Research | Louisville | Kentucky | 40241 | United States |
| Clinical Trials Management, LLC | Covington | Louisiana | 70433 | United States |
| Avant Research Associates, LLC | Crowley | Louisiana | 70526 | United States |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| DermAssociates, LLC | Rockville | Maryland | 20850 | United States |
| Metro Boston Clinical Partners | Brighton | Massachusetts | 02135 | United States |
| Oakland Hills Dermatology, PC | Auburn Hills | Michigan | 48326 | United States |
| Michigan Dermatology Institute | Waterford | Michigan | 48328 | United States |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | United States |
| Cleaver Dermatology | Kirksville | Missouri | 63501 | United States |
| Vivida Dermatology | Las Vegas | Nevada | 89119 | United States |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11415 | United States |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | United States |
| Optima Research | Boardman | Ohio | 44512 | United States |
| Remington-Davis, Inc. | Columbus | Ohio | 43215 | United States |
| Optimed Research | Columbus | Ohio | 43235 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Peak Research, LLC | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Palmetto Clinical Trial Services, LLC | Anderson | South Carolina | 29621 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| International Clinical Research - Tennessee, LLC | Murfreesboro | Tennessee | 37130 | United States |
| Arlington Research Center, Inc. | Arlington | Texas | 76011 | United States |
| Derm Research | Austin | Texas | 78759 | United States |
| J&S Studies | College Station | Texas | 77845 | United States |
| North Texas Center for Clinical Research | Frisco | Texas | 75034 | United States |
| Center for Clinical Studies, Ltd, LLP | Houston | Texas | 77004 | United States |
| Research Your Health | Plano | Texas | 75093 | United States |
| Houston Center for Clinical Research | Sugar Land | Texas | 77479 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Premier Clinical Research, LLC | Spokane | Washington | 99202 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2026 | Apr 28, 2026 | 12 | ||
| Jun 11, 2026 | Jul 7, 2026 | 13 |
| 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 |
| 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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| ID | Term |
|---|---|
| C000711049 | difamilast |
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