A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT05593445
Phase
PHASE2
Status
Completed

Conditions

  • Lichen Sclerosus

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib cream — DRUG
    Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
  • Vehicle cream — DRUG
    Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Study Details

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.

Key Dates

Start date
Nov 18, 2022
Status verified
Aug 2024
Primary completion
Sep 1, 2023
Completion
Dec 21, 2023

Study Design

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

Arms

  • Experimental: Ruxolitinib cream
    Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
  • Placebo Comparator: Vehicle Cream
    Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.

Primary Outcome Measure

Percentage of Participants With ITCH4 at Week 12 [ Time Frame: Baseline; Week 12 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Cahaba DermatologyBirminghamAlabama35244-
Mayo Clinic - ScottsdaleScottsdaleArizona85259-
UC IrvineIrvineCalifornia92697-
The Centers For Vulvovaginal DisordersWashington D.C.District of Columbia20037-
New Age Medical Research CorporationMiamiFlorida33186-
Circuit ClinicalWest SenecaNew York14224-
Unc Dermatology and Skin Cancer Center At Southern VillageChapel HillNorth Carolina27516-
Apex DermatologyAshtabulaOhio44004-
Bexley DermatologyBexleyOhio43209-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of Utah Health Care Midvalley Health Center DermatologyMurrayUtah84107-
Seattle Skin and Laser ClinicSeattleWashington98105-

Find similar trials in Birmingham, AL

By research site
Cahaba Dermatology· Birmingham, ALMayo Clinic - Scottsdale· Scottsdale, AZUC Irvine· Irvine, CAThe Centers For Vulvovaginal Disorders· Washington D.C., DCNew Age Medical Research Corporation· Miami, FLCircuit Clinical· West Seneca, NY

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