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COMPLETED Phase 2

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

NCT04091646 · View on ClinicalTrials.gov ↗

Study Summary

This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.

Conditions Studied

Interventions

  • DRUG Roflumilast Foam 0.3%
  • DRUG Vehicle foam

Study Locations (20)

Texas

  • Arcutis Biotherapeutics Clinical Site 13 — Arlington
  • Arcutis Biotherapeutics Clinical Site 11 — Austin
  • Arcutis Biotherapeutics Clinical Site 41 — College Station
  • Arcutis Biotherapeutics Clinical Site 25 — Houston

Florida

  • Arcutis Biotherapeutics Clinical Site 42 — Coral Gables
  • Arcutis Biotherapeutics Clinical Site 24 — Miami
  • Arcutis Biotherapeutics Clinical Site 12 — Tampa

California

  • Arcutis Biotherapeutics Clinical Site 19 — Fremont
  • Arcutis Biotherapeutics Clinical Site 21 — Santa Monica

Michigan

  • Arcutis Biotherapeutics Clinical Site 40 — Clinton Township
  • Arcutis Biotherapeutics Clinical Site 20 — Detroit

Illinois

  • Arcutis Biotherapeutics Clinical Site 10 — Rolling Meadows

Indiana

  • Arcutis Biotherapeutics Clinical Site 22 — Plainfield

Kentucky

  • Arcutis Biotherapeutics Clinical Site 15 — Louisville

Maryland

  • Arcutis Biotherapeutics Clinical Site 28 — Rockville

Trial Details

FieldValue
Enrollment Target 226 participants
Start Date 2019-12-04
Est. Completion 2020-08-21
Phase Phase 2

Sponsor

Arcutis Biotherapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04091646

The ClinicalTrials.gov registry entry for NCT04091646 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcutis Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Seborrheic Dermatitis appearing as the primary indexed condition, and to 2 interventions — of which Roflumilast Foam 0.3% is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04091646 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Texas, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04091646 about?

NCT04091646 is a clinical study titled "Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis". This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.

What is the current status of trial NCT04091646?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 226 participants. The study started on 2019-12-04. Estimated completion is 2020-08-21.

What conditions does trial NCT04091646 study?

This clinical trial studies the following conditions: Seborrheic Dermatitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04091646?

The interventions under investigation include: Roflumilast Foam 0.3% (DRUG), Vehicle foam (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04091646?

This trial is sponsored by Arcutis Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04091646 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial