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Janus Kinase (JAK) Inhibitor
Ruxolitinib Cream for Lichen Sclerosus
Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 weeks
Awards & highlights
Study Summary
This trial evaluates a cream to treat Lichen Sclerosus. It has two phases: a double-blind, vehicle-controlled phase and an open-label phase of 12 weeks each.
Who is the study for?
This trial is for individuals with Lichen Sclerosus, specifically those who have a confirmed diagnosis in the anogenital area and are experiencing itching. Participants must not be pregnant or planning pregnancy and should not have other infections or conditions that could explain their symptoms.Check my eligibility
What is being tested?
The study is testing Ruxolitinib cream's effectiveness and safety against a placebo (vehicle cream) over a 12-week period, followed by another 12 weeks where everyone receives Ruxolitinib to further assess its effects.See study design
What are the potential side effects?
While specific side effects of Ruxolitinib cream are not listed here, similar medications can cause skin irritation, headaches, dizziness, and increased risk of infection. The trial will monitor participants closely for any adverse reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with ITCH4
Secondary outcome measures
Change from baseline in Clinical Lichen Sclerosus Score (CLISSCO) score
Pain
Number of Treatment Emergent Adverse Events (TEAEs))
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ruxolitinib creamExperimental Treatment2 Interventions
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.
Group II: Vehicle CreamPlacebo Group1 Intervention
Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib cream
2022
Completed Phase 3
~1850
Vehicle cream
2011
Completed Phase 3
~5360
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,104 Total Patients Enrolled
Haq Nawaz, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have a specific condition affecting the anal or genital area.You are suspected of having other conditions that cause vaginal symptoms such as yeast infection, chlamydia, trichomoniasis, gonorrhea, bacterial vaginosis, or herpes.You have genital or vulvar sores that are not related to lichen sclerosus.You have a long-term or recent infection that needs to be treated with strong medications within 2 weeks before the study starts.Your initial IGA score is 2 or higher for LS.You have a score of 4 or higher for itching in the anogenital area before starting the study.Your lab test results do not meet the requirements set by the study.Diagnosed with LS in the anogenital area through a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib cream
- Group 2: Vehicle Cream
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently openings for enrolment in this clinical trial?
"As per the details on clinicaltrials.gov, this medical investigation is no longer taking in patients. It was first announced on November 18th 2022 and its most recent update took place a few days ago - November 14th 2022. However, fortunately there are 10 other trials that still have vacancies available for interested participants."
Answered by AI
What potential hazards exist when utilizing Ruxolitinib cream?
"Given its Phase 2 trial status, our team at Power inferred that the safety of Ruxolitinib cream is a level two. As such, there are some data points affirming security but none indicating efficacy."
Answered by AI
How many facilities are overseeing the administration of this research project?
"There are 8 medical sites recruiting for this trial, such as Bexley Dermatology in Bexley, Clinique Rsf in Quebec and K Papp Clinical Research Inc. in Waterloo."
Answered by AI
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