NCT04091646Phase 2Completed

Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

Study sponsor: Arcutis Biotherapeutics, Inc. · ARQT

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2020-08-18Actual

Enrollment · participants226Actual

Source updated2023-07-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Seborrheic Dermatitis

Treatments or interventions studied

Roflumilast Foam 0.3%DrugAlso known as ARQ-154
Vehicle foamDrugAlso known as Placebo

Primary outcomes · main study measures

Read the study measures

measure: Achievement of Investigator Global Assessment (IGA) Success at Week 8; description: The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.; timeFrame: Week 8

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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