Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus (NCT04908280) | Clinical Trial Compass
CompletedPhase 2
Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
United States10 participantsStarted 2022-05-04
Plain-language summary
The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability to understand and comply with the protocol and provide informed consent.
* Speaks English.
* Age ≥ 18 years.
* Clinical diagnosis of discoid lupus as assessed by the PI.
* At least one active (inflamed) discoid lesion with an IGA score of ≥ 3 and with a diameter ≥ 1cm at screening and baseline. Two lesions with equal scores will be necessary if consenting to pre-and post-treatment biopsies.
* Maximum body surface area of 20%.
Exclusion Criteria:
* Unwillingness or inability to complete informed consent process or comply with the study protocol.
* Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed during the study.
* History of coagulopathy, pulmonary embolism or deep venous thrombosis.
* History of cutaneous squamous cell carcinoma localized to the treatment area.
* Serum creatinine \> 1.5 mg/dL, or alanine aminotransferase or aspartate aminotransferase \> 1.5 × upper limit of normal.
* Other dermatologic disease besides discoid lupus whose presence or treatments could complicate assessments.
* Other diseases besides dermatologic disorders whose treatment could complicate assessments. Subjects with systemic lupus erythematosus are permitted as long as they do not have unstable disease and meet all other criteria, including the exclusion criteria for systemic immunosuppressive or immunomodulating drugs (below).
* Topical treatments for discoid lupus within 2 weeks of Visit 2.
* Systemic immunosuppressive or imm…
What they're measuring
1
Mean Severity of Disease as Measured by the Investigator's Global Assessment