A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis

Part of paid clinical trials in Hoover, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT03257644
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with atopic dermatitis (AD).

Key Dates

Start date
Sep 21, 2017
Status verified
Nov 2020
Primary completion
Oct 7, 2020
Completion
Oct 7, 2020

Study Design

Enrollment
70 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Ruxolitinib phosphate cream 0.5%.
  • Experimental: Cohort 2
    Ruxolitinib phosphate cream 1.5%.
  • Experimental: Cohort 3
    Ruxolitinib phosphate cream 0.75%.
  • Experimental: Cohort 4
    Ruxolitinib phosphate cream 1.5%.
  • Experimental: Cohort 5
    Ruxolitinib phosphate cream 0.75%.
  • Experimental: Cohort 6
    Ruxolitinib phosphate cream 1.5%.

Primary Outcome Measure

Participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Screening through 30-37 days after end of treatment, up to approximately 12 weeks. ]

Locations (23)

FacilityCityStateZIPSite coordinators
Cahaba DermatologyHooverAlabama35244-
Desert Sky DermatologyGilbertArizona85295-
Applied Research Center of ArkansasLittle RockArkansas72212-
Orange County Research CenterAnaheimCalifornia92801-
Children'S Hospital Los Angeles SpecialtLos AngelesCalifornia90027-
Rady Children'S Hospital - San DiegoSan DiegoCalifornia92123-
National Jewish HealthDenverColorado80206-
Olympian Clinical ResearchLargoFlorida33770-
Acevedo Clinical ResearchMiamiFlorida33142-
Floridian Research Institute LlcMiamiFlorida33145-
Rm Medical Research IncMiamiFlorida33174-
Olympian Clinical ResearchTampaFlorida33609-
Iact HealthColumbusGeorgia31904-
Advanced Clinical ResearchBoiseIdaho83713-
Northwestern UniversityChicagoIllinois60611-
The Indiana Clincal Trials CenterPlainfieldIndiana46168-
David Fivenson, Md, PllcAnn ArborMichigan48103-
Wake Research Associates LlcRaleighNorth Carolina27612-
Ohio Pediatric Research AssociationDaytonOhio45414-
Cyn3Rgy Research - Clinedge - PpdsGreshamOregon97030-
Penn State Hershey Medical CenterHersheyPennsylvania17033-
Progressive Clinical ResearchSan AntonioTexas78213-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-

Find similar trials in Hoover, AL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Cahaba Dermatology· Hoover, ALDesert Sky Dermatology· Gilbert, AZApplied Research Center of Arkansas· Little Rock, AROrange County Research Center· Anaheim, CAChildren'S Hospital Los Angeles Specialt· Los Angeles, CARady Children'S Hospital - San Diego· San Diego, CA

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