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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 Sep 1, 2026, 1:41 PM 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 24, 2021
Primary completion
May 27, 2024
Completion
May 27, 2024
Last update posted
Dec 22, 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 22, 2025 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04804605 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →