Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapinarof cream | Experimental | Tapinarof cream, 1%, applied topically once daily |
|
| Vehicle cream | Placebo Comparator | Vehicle cream is applied topically once daily for up to 8-weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapinarof cream, 1% | Drug | Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8 | The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. |
| Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period | The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint.. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. | Baseline to the end of the Open-Label Period, up to 56 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8. | The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the %BSA affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. A higher EASI score represents more severe disease. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Lead Late-Stage Clinical Development | Contact | 551-430-6000 | studysites@organon.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Lead Late-Stage Clinical Development | Organon and Co | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AllerVie Clinical Research | Recruiting | Birmingham | Alabama | 35209 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Following a screening period of up to 30 days, eligible participants will be randomly assigned to one of two groups for up to 8 weeks. During this time-called the Double-Blind Period-2 out of 3 participants will receive the active treatment (tapinarof cream, 1%), while 1 out of 3 will receive a vehicle cream (placebo).
Following completion of the Double-blind period, participants will enter the 48-week Open Label Period and will be treated as needed.
Not provided
Not provided
Not provided
|
| Vehicle Cream | Drug | Applied topically once daily to lesions on participant's skin during the Double-Blind period. |
|
| Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. |
| Mean change in percentage of total body surface area (%BSA) affected from Baseline to Week 8 | Assessment of %BSA is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% [10 handprints], upper extremities = 20% [20 handprints], trunk (including axillae and groin) = 30% [30 handprints], lower extremities, including buttocks, = 40% [40 handprints]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall. | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. |
| Percentage of participants with ≥ 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8 | Severity Index (EASI) score from Baseline to Week 8 Description: The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease. | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks. |
| Number of participants with one or more Treatment Emergent Adverse Events (TEAEs) | TEAEs are AEs that started on or after the first dose of study medication. | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks |
| Number of participants with one or more Treatment Emergent Adverse Events (TEAEs) | TEAEs are AEs that started on or after the first dose of study medication. | Baseline to the end of the Open-Label Period, up to 56 weeks |
| Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs) | TEAEs are AEs that started on or after the first dose of study medication. | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks . |
| Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs) | TEAEs are AEs that started on or after the first dose of study medication. | Baseline to the end of the Open-Label Period, up to 56 weeks. |
| Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall) | The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation. | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks |
| Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall) | The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation. | Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks. |
| Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas) | The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation. | Baseline to last planned visit in the Double-Blind Period, up to 8 weeks |
| Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas) | The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation. | Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks. |
| Dermatology Trial Associates | Recruiting | Bryant | Arkansas | 72022 | United States |
|
| Dermatology Research Associates | Recruiting | Los Angeles | California | 90045 | United States |
|
| Integrative Skin Science and Research | Recruiting | Sacramento | California | 95815 | United States |
|
| Allergy and Asthma Medical Group and Research Center | Recruiting | San Diego | California | 92123 | United States |
|
| Clinical Trials Research Institute | Recruiting | Thousand Oaks | California | 91320 | United States |
|
| Clarity Dermatology | Recruiting | Castle Rock | Colorado | 80109 | United States |
|
| Skin Care Research, LLC. | Recruiting | Boca Raton | Florida | 33486 | United States |
|
| APEX Clinical Trials | Recruiting | Jacksonville | Florida | 32256 | United States |
|
| TruDerm Research | Recruiting | Wellington | Florida | 33449 | United States |
|
| Cleaver Medical Group Dermatology, Inc | Recruiting | Cumming | Georgia | 30040 | United States |
|
| Ada West Research | Recruiting | Meridian | Idaho | 83646 | United States |
|
| Endeavor Health Clinical Trials Center | Recruiting | Skokie | Illinois | 60077 | United States |
|
| Dawes Fretzin Clinical Research Group, LLC | Recruiting | Indianapolis | Indiana | 46250 | United States |
|
| The Indiana Clinical Trials Center, PC | Recruiting | Plainfield | Indiana | 46168 | United States |
|
| Equity Medical, LLC | Recruiting | Bowling Green | Kentucky | 42104 | United States |
|
| Lawrence J Green, MD LLC | Recruiting | Rockville | Maryland | 20850 | United States |
|
| Oakland Hills Dermatology | Recruiting | Auburn Hills | Michigan | 48326 | United States |
|
| Minnesota Clinical Study Center | Recruiting | New Brighton | Minnesota | 55112 | United States |
|
| SKY Integrative Medical Center | Recruiting | Ridgeland | Mississippi | 39157 | United States |
|
| MediSearch Clinical Trials | Recruiting | Saint Joseph | Missouri | 64506 | United States |
|
| Skin Cancer and Dermatology Institute | Recruiting | Reno | Nevada | 89509 | United States |
|
| Forest Hills Dermatology Group | Recruiting | Kew Gardens | New York | 11415 | United States |
|
| Bobby Buka MD, PC | Recruiting | New York | New York | 10012 | United States |
|
| Equity Medical, LLC | Recruiting | The Bronx | New York | 10455 | United States |
|
| The University of North Carolina Dermatology and Skin Cancer Center | Recruiting | Chapel Hill | North Carolina | 27516 | United States |
|
| Cincinnati Children's Hospital Medical Center | Not yet recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Dermatologists of Central States, LLC | Recruiting | Fairborn | Ohio | 45324 | United States |
|
| Allergy Asthma and Clinical Research Center | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
|
| Oregon Dermatology and Research Center | Recruiting | Portland | Oregon | 97210 | United States |
|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| National Allergy and Asthma Research, LLC. | Recruiting | North Charleston | South Carolina | 29420 | United States |
|
| The University of Texas Health Science Center at Houston | Recruiting | Bellaire | Texas | 77401 | United States |
|
| Dermatology Treatment and Research Center | Recruiting | Dallas | Texas | 75230 | United States |
|
| Stryde Research - Epiphany Dermatology | Recruiting | Southlake | Texas | 76092 | United States |
|
| Dermatology Specialists of Spokane | Recruiting | Spokane | Washington | 99202 | United States |
|
| Dermatology Research Institute | Recruiting | Calgary | Alberta | T2J 7E1 | Canada |
|
| CARe Clinic (Central Alberta Research Clinic) | Recruiting | Red Deer | Alberta | T4P 1K4 | Canada |
|
| Dr. Chih-Ho Hong Medical Inc. | Recruiting | Surrey | British Columbia | V3R 6A7 | Canada |
|
| Manitoba Allergy Research Inc. | Recruiting | Winnipeg | Manitoba | R3J 0S9 | Canada |
|
| Maritime Dermatology | Recruiting | Halifax | Nova Scotia | B3K 5R3 | Canada |
|
| Halton Pediatric Allergy | Recruiting | Burlington | Ontario | L7L 6W6 | Canada |
|
| Triple A Lab Inc. | Recruiting | Hamilton | Ontario | L8S 1G5 | Canada |
|
| Allergy Research Canada Inc. | Recruiting | Niagara Falls | Ontario | L2H 1C4 | Canada |
|
| Dr. Rachel Asiniwasis Medical Professional Corporation | Recruiting | Regina | Saskatchewan | S4V 1R9 | Canada |
|
| Skinsense Medical Research | Recruiting | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C571829 | tapinarof |
Not provided
Not provided
Not provided