MedDataX Logo

Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

NCT ID: NCT04973228

Last Updated: 2024-03-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2022-04-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

NCT04773587

Atopic Dermatitis Eczema
COMPLETED PHASE3

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

NCT04845620

Atopic Dermatitis Eczema
COMPLETED PHASE3

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

NCT04804605

Atopic Dermatitis Eczema
COMPLETED PHASE3

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

NCT04773600

Atopic Dermatitis Eczema
COMPLETED PHASE3

Topical Roflumilast in Adults With Atopic Dermatitis

NCT01856764

Atopic Dermatitis
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seborrheic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Roflumilast Foam 0.3%

Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.

Group Type EXPERIMENTAL

Roflumilast Foam

Intervention Type DRUG

Roflumilast 0.3% foam for topical application

Vehicle Foam

Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks.

Group Type PLACEBO_COMPARATOR

Vehicle Foam

Intervention Type DRUG

Vehicle foam for topical application

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Roflumilast Foam

Roflumilast 0.3% foam for topical application

Intervention Type DRUG

Vehicle Foam

Vehicle foam for topical application

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ARQ-154

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
* Males and females ages 9 years and older at the time of consent.
* Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
* Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
* An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.
* Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
* Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
* Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
* Subjects in good health as judged by the Investigator.
* Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Exclusion Criteria

* Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
* Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
* Previous treatment with ARQ-154 or ARQ-151.
* Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
* Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
* Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
* Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Berk, MD

Role: STUDY_DIRECTOR

Arcutis Biotherapeutics, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arcutis Biotherapeutics Clinical Site 01

Scottsdale, Arizona, United States

Site Status

Arcutis Biotherapeutics Clinical Site 45

Encinitas, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 46

San Diego, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 64

San Diego, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 42

Coral Gables, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 57

Delray Beach, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 33

Largo, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 31

North Miami Beach, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 65

Sanford, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 12

Tampa, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 10

Rolling Meadows, Illinois, United States

Site Status

Arcutis Biotherapeutics Clinical Site 03

Indianapolis, Indiana, United States

Site Status

Arcutis Biotherapeutics Clinical Site 22

Plainfield, Indiana, United States

Site Status

Arcutis Biotherapeutics Clinical Site 15

Louisville, Kentucky, United States

Site Status

Arcutis Biotherapeutics Clinical Site 04

Lake Charles, Louisiana, United States

Site Status

Arcutis Biotherapeutics Clinical Site 02

Rockville, Maryland, United States

Site Status

Arcutis Biotherapeutics Clinical Site 28

Rockville, Maryland, United States

Site Status

Arcutis Biotherapeutics Clinical Site 40

Clinton Township, Michigan, United States

Site Status

Arcutis Biotherapeutics Clinical Site 20

Detroit, Michigan, United States

Site Status

Arcutis Biotherapeutics Clinical Site 14

Fridley, Minnesota, United States

Site Status

Arcutis Biotherapeutics Clinical Site 44

Saint Joseph, Missouri, United States

Site Status

Arcutis Biotherapeutics Clinical Site 19

Reno, Nevada, United States

Site Status

Arcutis Biotherapeutics Clinical Site 34

East Windsor, New Jersey, United States

Site Status

Arcutis Biotherapeutics Clinical Site 66

New York, New York, United States

Site Status

Arcutis Biotherapeutics Clinical Site 63

The Bronx, New York, United States

Site Status

Arcutis Biotherapeutics Clinical Site 23

High Point, North Carolina, United States

Site Status

Arcutis Biotherapeutics Clinical Site 70

Winston-Salem, North Carolina, United States

Site Status

Arcutis Biotherapeutics Clinical Site 18

Bexley, Ohio, United States

Site Status

Arcutis Biotherapeutics Clinical Site 71

Portland, Oregon, United States

Site Status

Arcutis Biotherapeutics Clinical Site 08

Broomall, Pennsylvania, United States

Site Status

Arcutis Biotherapeutics Clinical Site 27

Pittsburgh, Pennsylvania, United States

Site Status

Arcutis Biotherapeutics Clinical Site 06

Knoxville, Tennessee, United States

Site Status

Arcutis Biotherapeutics Clinical Site 13

Arlington, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 11

Austin, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 41

College Station, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 60

Houston, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 26

Pflugerville, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 72

Plano, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 54

San Antonio, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 24

San Antonio, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 07

West Jordan, Utah, United States

Site Status

Arcutis Biotherapeutics Clinical Site 17

Norfolk, Virginia, United States

Site Status

Arcutis Biotherapeutics Clinical Site 35

Calgary, Alberta, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 37

Surrey, British Columbia, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 47

Winnipeg, Manitoba, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 43

Fredericton, New Brunswick, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 16

London, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 29

Mississauga, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 30

North Bay, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 32

Peterborough, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 36

Waterloo, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 09

Westmount, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARQ-154-304

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
NCT05375955 COMPLETED PHASE2
Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis
NCT03916081 COMPLETED PHASE2
A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)
NCT00746382 WITHDRAWN PHASE2
Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
NCT06998056 COMPLETED PHASE2
Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study
NCT07297602 RECRUITING PHASE2
Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab
NCT05694884 RECRUITING PHASE2
Safety and Efficacy Study in Subjects With Seborrheic Dermatitis
NCT01703793 COMPLETED PHASE2
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT03422822 COMPLETED PHASE3
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
NCT03349060 COMPLETED PHASE3
Study of 0417 Ointment in the Treatment of Atopic Dermatitis
NCT01139450 COMPLETED PHASE3
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
NCT05608343 COMPLETED PHASE3
Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
NCT03575871 COMPLETED PHASE3
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
NCT03054428 COMPLETED PHASE3
Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
NCT03345914 COMPLETED PHASE3
Study of 0416 Ointment in the Treatment of Atopic Dermatitis
NCT01053247 COMPLETED PHASE3
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
NCT03011892 COMPLETED PHASE2
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT04875169 COMPLETED PHASE3
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
NCT03627767 COMPLETED PHASE3
Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis
NCT03389893 TERMINATED PHASE4
A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants
NCT04135560 COMPLETED PHASE1
Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis
NCT06631170 COMPLETED PHASE3
Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
NCT03562377 COMPLETED PHASE2
Distribution of Tacrolimus in Skin, Atopic Dermatitis
NCT00534508 COMPLETED PHASE2
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
NCT03720470 COMPLETED PHASE3
Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
NCT00691145 COMPLETED PHASE3