A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
Incyte Corporation
Study ID
NCT00778700
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo Cream — OTHER
    Cream with no active drug
  • Ruxolitinib Phosphate — DRUG
    Ruxolitinib phosphate cream

Study Details

The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.

Key Dates

Start date
Oct 28, 2008
Status verified
Jan 2022
Primary completion
Jun 26, 2009
Completion
Jun 26, 2009

Study Design

Enrollment
199 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Vehicle Cream
    Vehicle cream, applied topically, once daily from Day 1 to Week 12.
  • Experimental: Ruxolitinib Phosphate 0.5% Cream
    Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
  • Experimental: Ruxolitinib Phosphate 1.0% Cream
    Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
  • Experimental: Ruxolitinib Phosphate 1.5% Cream
    Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.

Primary Outcome Measure

Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 [ Time Frame: From Baseline (Day 1) to Day 84 ]

Locations (28)

FacilityCityStateZIPSite coordinators
-Hot SpringsArkansas--
-Los AngelesCalifornia--
-San DiegoCalifornia--
-Santa MonicaCalifornia--
-VallejoCalifornia--
-New HavenConnecticut--
-MiamiFlorida--
-Ormond BeachFlorida--
-NapervilleIllinois--
-WheatonIllinois--
-EvansvilleIndiana--
-South BendIndiana--
-BostonMassachusetts--
-Clinton TownshipMichigan--
-FridleyMinnesota--
-St LouisMissouri--
-AlbuquerqueNew Mexico--
-RochesterNew York--
-NormanOklahoma--
-SimpsonvilleSouth Carolina--
-AustinTexas--
-College StationTexas--
-DallasTexas--
-HoustonTexas--
-Salt Lake CityUtah--
-NorfolkVirginia--
-Walla WallaWashington--
-MadisonWisconsin--

Find similar trials in Hot Springs, AR

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease

Related Studies