Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04091646 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
A Phase 2 study of Seborrheic Dermatitis, sponsored by Arcutis Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 226
- Enrollment target
- 20
- Study locations
NCT04091646: Completed Phase 2 study of Seborrheic Dermatitis, sponsored by Arcutis Biotherapeutics.
NCT04091646 is a Phase 2 study of Seborrheic Dermatitis that has completed, run by Arcutis Biotherapeutics. The registered enrollment target is 226 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04091646, a Phase 2 study of Seborrheic Dermatitis, has completed, sponsored by Arcutis Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 226 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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 obs
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
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2019-12-04 |
| Est. Completion | 2020-08-21 |
| Phase | Phase 2 |
What the finished NCT04091646 record still lists
NCT04091646 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% higher).
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.
NCT04091646 names 20 study sites across 13 states, led by Texas, Florida, California.
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.
What interventions are being tested in trial NCT04091646?
The interventions under investigation include: Roflumilast Foam 0.3% (DRUG), Vehicle foam (DRUG).
Who is sponsoring clinical trial NCT04091646?
This trial is sponsored by Arcutis Biotherapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Seborrheic Dermatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04091646's enrollment target sits among peer trials
226 267th of 2000 higher than 1,734 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04419272 · 226 participants · Phase 4
Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
- NCT05449002 · 226 participants · NA
Digital Single Session Intervention for Youth Mental Health
- NCT05488054 · 226 participants · NA
Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery
- NCT05924477 · 226 participants · NA
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI