NCT04773587Phase 3Completed

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic 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 completion2022-08-30Actual

Enrollment · participants654Actual

Source updated2024-10-09Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Atopic Dermatitis Eczema

Treatments or interventions studied

Roflumilast Cream 0.15%DrugAlso known as ARQ-151
Vehicle CreamDrug

Primary outcomes · main study measures

Read the study measures

measure: Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4; description: The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity.; timeFrame: Week 4

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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