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Topical Therapy

Ruxolitinib Cream for Discoid Lupus

Phase 2
Recruiting
Led By Robert Bissonnette, MD
Research Sponsored by Innovaderm Research Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subject of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1
Male or female subject 18 years of age or older at the time of consent
Must not have
Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study
Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12 and 24
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a cream called ruxolitinib on adults with discoid lupus to see how well it works.

Who is the study for?
This trial is for adults with discoid lupus erythematosus, a chronic skin condition. Participants should have stable disease and be willing to apply cream treatments as directed. Specific eligibility details are not provided, but typically trials exclude those with certain health conditions or who are taking conflicting medications.
What is being tested?
The study tests the effectiveness of Ruxolitinib 1.5% cream in treating discoid lupus erythematosus. It's a single-blind study where participants use the cream normally on some lesions and under occlusion (covered) at night on others to compare results.
What are the potential side effects?
While specific side effects aren't listed here, Ruxolitinib may commonly cause itching, redness at the application site, and potential systemic effects like infections due to immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children and have tested negative for pregnancy.
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I am 18 years old or older.
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I have been diagnosed with discoid lupus erythematosus.
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My skin condition is rated as moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, or planning to become pregnant during the study.
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I do not have a skin condition that could affect study results.
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I am 50 or older with a history of heart issues or stroke.
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I have hepatitis B or C.
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I haven't used any skin medication that could affect my condition in the last 2 weeks.
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I have used ruxolitinib cream (OpzeluraTM).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in target lesion CLASI-A score
Change from baseline in target lesion SADDLE-A
Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)
+1 more
Other study objectives
Cutaneous Lupus Erythematosus Quality of Life (CLEQol)
Dermatology Life Quality Index (DLQI)
Numeric Rating Scale(NRS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: ruxolitinib 1.5% cream (Sequence 1)Experimental Treatment3 Interventions
ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
Group II: ruxolitinib 1.5% cream ( Sequence 2)Experimental Treatment3 Interventions
ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2

Find a Location

Who is running the clinical trial?

Innovaderm Research Inc.Lead Sponsor
48 Previous Clinical Trials
3,200 Total Patients Enrolled
Robert Bissonnette, MDPrincipal InvestigatorInnovaderm Research Inc.
25 Previous Clinical Trials
2,719 Total Patients Enrolled
~4 spots leftby Feb 2025
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