๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-03-21

Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus (NCT06261021)

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Innovaderm Research Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (15 items).

Location: INNO-6051 Site 03 โ€” Fredericton, New Brunswick

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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 โ‰ฅ 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.

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • INNO-6051 Site 03 โ€” Fredericton, New Brunswick
  • Innovaderm Research Inc. โ€” Montreal, Quebec

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—