drugset / Trial / NCT03539601
A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2018-04-27
- Primary completion
- 2020-12-11
- Completion
- 2020-12-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crisaborole | Small molecule | 2 % | Topical |
| Comparator | Hydrocortisone Butyrate | Unknown | 0.1 % | Topical |
| Comparator | Pimecrolimus | Small molecule | 1 % | Topical |