A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03920852|
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Ruxolitinib cream||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis|
|Estimated Study Start Date :||May 17, 2019|
|Estimated Primary Completion Date :||December 27, 2019|
|Estimated Study Completion Date :||December 27, 2019|
|Experimental: Ruxolitinib cream||
Drug: Ruxolitinib cream
Ruxolitinib 1.5% cream applied twice daily.
Other Name: INCB018424 phosphate cream
- Number of treatment-emergent adverse events [ Time Frame: Up to 127 days ]Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first application of study drug.
- Plasma concentration of ruxolitinib [ Time Frame: Up to 127 days ]
- Cmax of ruxolitinib [ Time Frame: Up to 127 days ]Maximum measured plasma concentration.
- Tmax of ruxolitinib [ Time Frame: Up to 127 days ]Time to achieve the observed maximum plasma concentration.
- AUC0-12 of ruxolitinib [ Time Frame: Up to 127 days ]Area under the concentration-time curve from 0 to 12 hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920852
|Contact: Incyte Corporation Call Center (US)||email@example.com|
|Contact: Incyte Corporation Call Center (ex-US)||+800 firstname.lastname@example.org|
|United States, Florida|
|San Marcus Research Clinic, Inc.||Not yet recruiting|
|Miami Lakes, Florida, United States, 33014|
|RM Medical Research, INC.||Not yet recruiting|
|Miami, Florida, United States, 33174|
|United States, Texas|
|Progressive Clinical Research, P.A.||Not yet recruiting|
|San Antonio, Texas, United States, 78213|
|United States, Virginia|
|Clinical Research Partners||Not yet recruiting|
|Richmond, Virginia, United States, 23220|
|Innovaderm Research Inc.||Not yet recruiting|
|Montréal, Quebec, Canada, H2K 4L5|
|Study Director:||Michael E. Kuligowski, MD||Incyte Corporation|