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CompletedPhase 2

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

Key facts

Who runs it
Incyte Corporation
Where
Arlington, Baton Rouge, Bexley, Birmingham, Columbus, Indianapolis, Las Vegas, Los Angeles, Mayfield Heights, Murfreesboro, Murray, New Brighton, New Orleans, New York, Norman, Pflugerville, Philadelphia, Phoenix, Portland, Rockville, Scottsdale, and Skokie, United StatesSee the 22 sitesAlso in 1 other country, 2 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
64 people enrolled
Started
23 Nov 2022
Ended
26 Feb 2024
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Ruxolitinib cream
  • Vehicle cream
Record updated
24 October 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Clinical diagnosis of LP with predominant cutaneous involvement
  • IGA score of 3 or 4 at screening and baseline
  • Baseline LP-related Itch NRS score ≥ 4
  • Willingness to avoid pregnancy or fathering children

Who cannot take part

  • Concurrent conditions and history of other diseases:; Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP; Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety; Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety; Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome); Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline; Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week before baseline
  • Laboratory values outside of the protocol-defined criteria
  • Pregnant or lactating participants, or those considering pregnancy during the period of their study participation
  • Other exclusive criteria may apply

Where in United States

Also in 1 other country, 2 sites

  • Arlington Center for DermatologyArlington, United States
  • Delricht Clinical Research-Clinedge-Ppds Baton RougeBaton Rouge, United States
  • Bexley DermatologyBexley, United States
  • Cahaba DermatologyBirmingham, United States
  • ClinOhio Research ServicesColumbus, United States
  • Dawes Fretzin Clinical Research Group, LLCIndianapolis, United States
  • JDR Dermatology ResearchLas Vegas, United States
  • Wallace of Beverly HillsLos Angeles, United States
  • Apex Clinical Research CenterMayfield Heights, United States
  • International Clinical Research (IC Research) - MurfreesboroMurfreesboro, United States
  • University of Utah Health Care Midvalley Health Center DermatologyMurray, United States
  • Minnesota Clinical Study CenterNew Brighton, United States
  • Delricht Research-Touro Medical CenterNew Orleans, United States
  • OPTISKINNew York, United States
  • Central Sooner ResearchNorman, United States
  • Austin Institute For Clinical Research Aicr PflugervillePflugerville, United States
  • University of Pennsylvania Perelman School of MedicinePhiladelphia, United States
  • Medical Dermatology Specialists PhoenixPhoenix, United States
  • Oregon Medical Research CenterPortland, United States
  • DermassociatesRockville, United States
  • Mayo Clinic - ArizonaScottsdale, United States
  • NorthShore Medical Group Dermatology SkokieSkokie, United States

About the trial

What the trial wants to find out

The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.

The 2 groups in the trial

  • Ruxolitinib creamTreatment being tested

    Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.

    Treatment: Ruxolitinib cream and Vehicle cream

  • Vehicle CreamPlacebo, for comparison

    Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Publications
Record updated
24 October 2024