A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)
Public ClinicalTrials.gov record NCT04921969. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).
Study identification
- NCT ID
- NCT04921969
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 19, 2021 (Actual)
- Primary completion
- May 10, 2023 (Actual)
- Completion
- Apr 8, 2024 (Actual)
- Last update posted
- Mar 28, 2025
2021 – 2024
United States locations
- U.S. sites
- 64
- U.S. states
- 27
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | — |
| Cahaba Dermatology | Hoover | Alabama | 35244 | — |
| Physicians Research Group Ii | Gilbert | Arizona | 85295 | — |
| Cct Research With Center For Dermatology and Plastic Surgery | Scottsdale | Arizona | 85260 | — |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | — |
| First Oc Dermatology | Fountain Valley | California | 92708 | — |
| Iact Health | Los Angeles | California | 90017 | — |
| Metropolis Dermatology | Los Angeles | California | 90017 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Madera Family Medical Group | Madera | California | 93637 | — |
| Allergy & Asthma Associates of Southern California | Mission Viejo | California | 92691 | — |
| Palmtree Clinical Research-Clinedge-Ppds | Palm Springs | California | 92262 | — |
| Integrated Research of Inland, Inc | Riverside | California | 92506 | — |
| Clinical Science Institute Clinical Research Specialists Inc | Santa Monica | California | 90404 | — |
| Phdermatology | Clearwater | Florida | 33756 | — |
| Life Clinical Trials Margate | Margate | Florida | 33063 | — |
| Acevedo Clinical Research | Miami | Florida | 33142 | — |
| Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc | Miami | Florida | 33146 | — |
| The Childrens Skin Center Csc Miami | Miami | Florida | 33155 | — |
| Entrust Clinical Research | Miami | Florida | 33156 | — |
| Ciocca Dermatology Pa | Miami | Florida | 33173 | — |
| Forcare Clinical Research | Tampa | Florida | 33624 | — |
| Aeroallergy Research Lab of Savannah | Savannah | Georgia | 31406 | — |
| Northwestern Memorial Hospital-Arkes Pavilion | Chicago | Illinois | 60611 | — |
| Sneeze Wheeze and Itch Associates Llc | Normal | Illinois | 61761 | — |
| Northshore Medical Group Dermatology Skokie | Skokie | Illinois | 60076 | — |
| Dermatology Specialists Research Indiana | Clarksville | Indiana | 47129 | — |
| Dawes Fretzin Clinical Research Group Llc | Indianapolis | Indiana | 46250 | — |
| Kansas City Dermatology P.A. | Lenexa | Kansas | 66215 | — |
| Office of Michael W. Simon, Md | Nicholasville | Kentucky | 40356 | — |
| Meridian Clinical Research | Baton Rouge | Louisiana | 70808 | — |
| Delricht Clinical Research-Clinedge-Ppds Baton Rouge | Baton Rouge | Louisiana | 70809 | — |
| Delricht Research-Touro Medical Center | New Orleans | Louisiana | 70115 | — |
| Lawrence J. Green, Md. Llc | Rockville | Maryland | 20850 | — |
| Henry Ford Medical Center-New Center One | Detroit | Michigan | 48202 | — |
| Michigan Dermatology Institute | Waterford | Michigan | 48328 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Skin Specialists Pc the Advanced Skin Research Center | Omaha | Nebraska | 68144 | — |
| Dr Bobby Buka, Md Greenwich Village | New York | New York | 10012 | — |
| New York University Langone Medical Center-Fink Children'S Ambulatory Care Center | New York | New York | 10016 | — |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | — |
| Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc | Grants Pass | Oregon | 97527 | — |
| Cyn3Rgy Research-Clinedge-Ppds | Gresham | Oregon | 97030 | — |
| Velocity Clinical Research-Medford | Medford | Oregon | 97504 | — |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | — |
| Knight Cancer Institute At Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | 37130 | — |
| Arlington Research Center | Arlington | Texas | 76011 | — |
| Progressive Clinical Research | San Antonio | Texas | 78213 | — |
| Texas Dermatology Alamo Heights Office | San Antonio | Texas | 78218 | — |
| Allergy and Asthma Care of Waco, Pa | Waco | Texas | 76712 | — |
| Intermountain Clinical Research Icr Draper | Draper | Utah | 84020 | — |
| Springville Dermatology | Springville | Utah | 84663 | — |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | — |
| Skindc Clinic | Arlington | Virginia | 22209 | — |
| Pi Coor Clinical Research Llc | Burke | Virginia | 22015 | — |
| Clinical Research Partners Llc | Richmond | Virginia | 23220 | — |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | — |
| Children'S Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04921969, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 28, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04921969 live on ClinicalTrials.gov.