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The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib 1.5 % Cream | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib Cream | Drug | Ruxolitinib cream applied topically to the affected area as a thin film twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events reported for the first time or worsening of a pre-existing event after the first application of study drug. | Up to 24 weeks |
| Number of participants with TEAEs leading to treatment interruption, discontinuation | Number of participants with TEAEs leading to dose interruption or discontinuation | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter (PK): Cmax of INCB018424 | Defined as maximum observed plasma concentration of INCB018424. | Up to 24 weeks |
| Pharmacokinetics Parameter: Tmax of INCB018424 | Defined as the time to reach the maximum plasma concentration of INCB018424. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saguaro Dermatology | Recruiting | Phoenix | Arizona | 85008 | United States | |
| First Oc Dermatology |
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| Label | URL |
|---|---|
| Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa | View source |
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| Up to 24 weeks |
| Pharmacokinetics Parameter: AUC 0-12 of INCB018424 | Defined as the area under the plasma or serum concentration-time curve from Hour 0 to 12 hours of INCB018424. | Up to 24 weeks |
| Recruiting |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Amicis Research Center Valencia | Recruiting | Northridge | California | 91324 | United States |
| Children'S Hospital of Orange County | Recruiting | Orange | California | 92868 | United States |
| Clinical Trials Research Institute | Recruiting | Thousand Oaks | California | 91320 | United States |
| Clarity Dermatology | Recruiting | Castle Rock | Colorado | 80109 | United States |
| Advanced Pharma Cr, Llc | Not yet recruiting | Miami | Florida | 33147 | United States |
| International Clinical Research Tennessee Llc | Recruiting | Sanford | Florida | 32771 | United States |
| Lenus Research Medical Group, Llc | Recruiting | Sweetwater | Florida | 33172 | United States |
| Trueblue Clinical Research | Recruiting | Tampa | Florida | 33609 | United States |
| Emory University School of Medicine | Withdrawn | Atlanta | Georgia | 30322 | United States |
| Lane Dermatology and Dermatologic Surgery | Recruiting | Columbus | Georgia | 31904 | United States |
| Options Research Group, Llc | Recruiting | West Lafayette | Indiana | 47906 | United States |
| Equity Medical, Llc | Recruiting | Bowling Green | Kentucky | 42104 | United States |
| Delricht Research | Recruiting | Baton Rouge | Louisiana | 70809 | United States |
| Revival Research Institute, Llc Troy | Recruiting | Troy | Michigan | 48084 | United States |
| Red River Research Partners | Recruiting | Bolivar | Missouri | 65613 | United States |
| Dr Bobby Buka, Md Greenwich Village | Recruiting | New York | New York | 10012-1354 | United States |
| Equity Medical, Llc | Recruiting | New York | New York | 10019 | United States |
| Red River Research Partners | Recruiting | Fargo | North Dakota | 58103 | United States |
| Centricity Research Columbus | Recruiting | Columbus | Ohio | 43213 | United States |
| Unity Clinical Research | Recruiting | Oklahoma City | Oklahoma | 73118 | United States |
| Paddington Testing Co Inc | Recruiting | Philadelphia | Pennsylvania | 19103 | United States |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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