Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus (NCT06261021) is a Phase 2 interventional studying Discoid Lupus Erythematosus, sponsored by Innovaderm Research Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Discoid Lupus Erythematosus and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female subject 18 years of age or older at the time of consent. - Confirmed DLE diagnosis. - Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1. - Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day 1. - Subject has no known history of latent or active tuberculosis (TB) infection. - Subject is willing to participate and is capable of giving willing to sign a consent form. Note: Consent must be obtained prior to any study-related procedures. - Subjects must be willing to comply with all study procedures and must be available for the duration of the study. Who Should NOT Join This Trial: - 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. - Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening. - Subject is known to have immune deficiency or is immunocompromised. - Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots. - Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human weakened immune system virus \[HIV\]). - Subject is known to have hepatitis B or hepatitis C viral infection. - Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices. - Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Male or female subject 18 years of age or older at the time of consent. * Confirmed DLE diagnosis. * Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1. * Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day 1. * Subject has no known history of latent or active tuberculosis (TB) infection. * Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. * Subjects must be willing to comply with all study procedures and must be available for the duration of the study. Exclusion Criteria: * 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. * Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening. * Subject is known to have immune deficiency or is immunocompromised. * Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots. * Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]). * Subject is known to have hepatitis B or hepatitis C viral infection. * Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices. * Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab. * Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1. * Subject has a known or suspected allergy to ruxolitinib. * Subject has used ruxolitinib cream (OpzeluraTM). * Subject has used JAK inhibitors for conditions other than DLE or other forms of lupus within 4 weeks prior to Day 1. * Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

Treatments Being Tested

DRUG

Ruxolitinib 1.5% cream

Topical application of Ruxolitinib 1.5% cream

PROCEDURE

Application without occlusion in Area 1

Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.

PROCEDURE

Application under occlusion at night in Area 2

Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.

PROCEDURE

Application under occlusion at night in Area 1

Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.

PROCEDURE

Application without occlusion in Area 2

Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

INNO-6051 Site 03

Fredericton, New Brunswick, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06261021), the sponsor (Innovaderm Research Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06261021 clinical trial studying?

This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06261021?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06261021?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06261021. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06261021. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.