Ruxolitinib in Seborrheic Dermatitis (NCT05787860) | Clinical Trial Compass
CompletedPhase 2
Ruxolitinib in Seborrheic Dermatitis
United States45 participantsStarted 2022-11-15
Plain-language summary
This study is an open-label prospective interventional trial that will assess the efficacy of ruxolitinib in the treatment of seborrheic dermatitis. It will also attempt to characterize the molecular immune profiles of patients with SD at week 0 and week 4, with comparison to baseline profiles in healthy control subjects.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria For SD Subjects:
* Male or female subjects ≥ 18 years of age at the time of signing the informed consent document.
* Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
* Subject is able to adhere to the study visit schedule and other protocol requirements.
* Baseline SD score of IGA ≥ 3 with facial involvement
* Subject agrees to discontinue all treatments for SD from screening through study completion aside from the study drug
* Subject has failed an adequate course of treatment with at least one available therapy (topical antifungals or low-potency topical corticosteroids)
* Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
* Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on the study drug and for at least 90 days after the last application of the study drug, male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
* Option 1: Any one of the following highly effective contraceptive …
What they're measuring
1
Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4