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Topical Therapy

ruxolitinib 1.5% cream (Sequence 1) 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 12 and 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 12 and 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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 outcome measures

Cutaneous Lupus Erythematosus Quality of Life (CLEQol)

Dermatology Life Quality Index (DLQI)

Numeric Rating Scale(NRS)

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Innovaderm Research Inc.Lead Sponsor

48 Previous Clinical Trials

3,196 Total Patients Enrolled

Robert Bissonnette, MDPrincipal InvestigatorInnovaderm Research Inc.

25 Previous Clinical Trials

2,715 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to enroll in this ongoing study?

"According to clinicaltrials.gov, this particular study is not actively seeking participants. Originally posted on 2/15/2024 and last modified on 2/14/2024, recruitment has ceased. Nonetheless, there are currently 147 other trials open for enrollment at present."

Answered by AI

Has the 1.5% cream formulation of ruxolitinib, as noted in Sequence 1, been granted approval by the FDA?

"Our team at Power has evaluated the safety of ruxolitinib 1.5% cream (Sequence 1) to be a 2 on the scale from 1 to 3. This rating is based on it being a Phase 2 trial without data supporting efficacy yet some evidence backing its safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus

2024. "Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261021.

All > Systemic Lupus Erythematosus > Lupus