Frontlight ResearchEarly access
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