A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD
Public ClinicalTrials.gov record NCT03539601. 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 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED, VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to \<18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.
Study identification
- NCT ID
- NCT03539601
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 237 participants
Conditions and interventions
Conditions
Interventions
- Crisaborole ointment, 2% Drug
- Hydrocortisone butyrate cream, 0.1% Drug
- Pimecrolimus cream, 1% Drug
- Crisaborole Vehicle Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years and older
- 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
- Apr 27, 2018 (Actual)
- Primary completion
- Dec 11, 2020 (Actual)
- Completion
- Dec 11, 2020 (Actual)
- Last update posted
- Jan 10, 2022
2018 – 2020
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dermatology Trial Associates | Bryant | Arkansas | 72022 | — |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | — |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | — |
| Lenus Research & Medical Group, LLC | Sweetwater | Florida | 33172 | — |
| ForCare Clinical Research | Tampa | Florida | 33613 | — |
| DS Research | Louisville | Kentucky | 40241 | — |
| M3-Wake Research, Inc. | Raleigh | North Carolina | 27612 | — |
| Arlington Research Center, Inc. | Arlington | Texas | 76011 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23502 | — |
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 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03539601, 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 Jan 10, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03539601 live on ClinicalTrials.gov.