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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovaderm Research Inc.

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ruxolitinib 1.5% cream
  • Application without occlusion in Area 1
  • Application under occlusion at night in Area 2
  • Application under occlusion at night in Area 1
  • Application without occlusion in Area 2

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators