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Completed Phase 3 Interventional Results available

Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

ClinicalTrials.gov ID: NCT04804605

Public ClinicalTrials.gov record NCT04804605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.

Study identification

NCT ID
NCT04804605
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Enrollment
1,220 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 25, 2021 (Actual)
Primary completion
May 28, 2024 (Actual)
Completion
May 28, 2024 (Actual)
Last update posted
Dec 23, 2025

2021 – 2024

United States locations

U.S. sites
76
U.S. states
30
U.S. cities
67
Facility City State ZIP Site status
Arcutis Clinical Site 112 Birmingham Alabama 35209 —
Arcutis Clinical Site 73 Birmingham Alabama 35244 —
Arcutis Clinical Site 63 Scottsdale Arizona 85255 —
Arcutis Clinical Site 106 Bryant Arkansas 72022 —
Arcutis Clinical Site 116 Fort Smith Arkansas 72916 —
Arcutis Clinical Site 69 Beverly Hills California 90212 —
Arcutis Clinical Site 81 Inglewood California 90301 —
Clinical Site 08 San Francisco California 94132 —
Arcutis Clinical Site 31 Santa Monica California 90404 —
Arcutis Clinical Site 130 Thousand Oaks California 91320 —
Arcutis Clinical Site 123 Centennial Colorado 80112 —
Arcutis Clinical Site 59 Coral Gables Florida 33134 —
Arcutis Clinical Site 72 Coral Gables Florida 33146 —
Arcutis Clinical Site 79 Delray Beach Florida 33484 —
Arcutis Clinical Site 103 Hollywood Florida 33021 —
Clinical Site 04 Jacksonville Florida 32256 —
Arcutis Clinical Site 15 Largo Florida 33770 —
Arcutis Clinical Site 67 Miami Florida 33162 —
Arcutis Clinical Site 95 Miami Florida 33173 —
Arcutis Clinical Site 68 Miami Florida 33174 —
Arcutis Clinical Site 29 Sanford Florida 32771 —
Clinical Site 01 Tampa Florida 33613 —
Arcutis Clinical Site 138 Wellington Florida 33449 —
Arcutis Clinical Site 47 Sandy Springs Georgia 30328 —
Arcutis Clinical Site 145 Boise Idaho 83706 —
Arcutis Clinical Site 13 Rolling Meadows Illinois 33770 —
Arcutis Clinical Site 93 Clarksville Indiana 47129 —
Clinical Site 22 Plainfield Indiana 46168 —
Arcutis Clinical Site 114 West Lafayette Indiana 47906 —
Clinical Site 03 Louisville Kentucky 40217 —
Arcutis Clinical Site 80 Covington Louisiana 70433 —
Arcutis Clinical Site 85 Lake Charles Louisiana 70605 —
Arcutis Clinical Site 24 Metairie Louisiana 70006 —
Arcutis Clinical Site 76 Rockville Maryland 20850 —
Arcutis Clinical Site 94 Bay City Michigan 48706 —
Arcutis Clinical Site 88 Clarkston Michigan 48346 —
Arcutis Clinical Site 58 Clinton Township Michigan 48038 —
Arcutis Clinical Site 66 Detroit Michigan 48202 —
Arcutis Clinical Site 132 Troy Michigan 48084 —
Clinical Site 10 New Brighton Minnesota 55112 —
Arcutis Clinical Site 102 Saint Joseph Missouri 64506 —
Arcutis Clinical Site 62 Reno Nevada 89509 —
Arcutis Clinical Site 71 East Windsor New Jersey 08520 —
Arcutis Clinical Site 96 Kew Gardens New York 11415 —
Arcutis Clinical Site 82 Rochester New York 14623 —
Arcutis Clinical Site 19 High Point North Carolina 27262 —
Arcutis Clinical Site 17 Gresham Oregon 97030 —
Arcutis Clinical Site 108 Portland Oregon 97210 —
Arcutis Clinical Site 16 Portland Oregon 97223 —
Arcutis Clinical Site 14 Portland Oregon 97239 —
Arcutis Clinical Site 53 Hershey Pennsylvania 17033 —
Arcutis Clinical Site 64 Newtown Square Pennsylvania 19073 —
Arcutis Clinical Site 25 Pittsburgh Pennsylvania 15213 —
Arcutis Clinical Site 101 Johnston Rhode Island 02919 —
Arcutis Clinical Site 77 Charleston South Carolina 29407 —
Arcutis Clinical Site 41 Charleston South Carolina 29425 —
Clinical Site 33 North Charleston South Carolina 29420 —
Arcutis Clinical Site 91 Summerville South Carolina 29486 —
Arcutis Clinical Site 60 Murfreesboro Tennessee 37130 —
Arcutis Clinical Site 34 Arlington Texas 76011 —
Clinical Site 23 Austin Texas 78759 —
Arcutis Clinical Site 84 Bellaire Texas 77401 —
Arcutis Clinical Site 21 College Station Texas 77845 —
Arcutis Clinical Site 126 Frisco Texas 75034 —
Arcutis Clinical Site 118 Grapevine Texas 76051 —
Arcutis Clinical Site 48 Houston Texas 77030 —
Arcutis Clinical Site 35 Houston Texas 77056 —
Arcutis Clinical Site 109 Katy Texas 77494 —
Clinical Site 20 San Antonio Texas 78213 —
Arcutis Clinical Site 49 San Antonio Texas 78218 —
Arcutis Clinical Site 74 Orem Utah 84058 —
Arcutis Clinical Site 36 West Jordan Utah 84088 —
Arcutis Clinical Site 51 Burke Virginia 22015 —
Arcutis Clinical Site 40 Norfolk Virginia 23502 —
Arcutis Clinical Site 12 Spokane Washington 99202 —
Arcutis Clinical Site 133 Kenosha Wisconsin 53142 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04804605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 23, 2025 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04804605 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →