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

June 12, 2023 updated by: Arcutis Biotherapeutics, Inc.

A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to subjects with seborrheic dermatitis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, L3P 1X2
        • Arcutis Biotherapeutics Clinical Site 31
      • Windsor, Ontario, Canada, N8W 1E6
        • Arcutis Biotherapeutics Clinical Site 30
  • United States
    • California
      • Fremont, California, United States, 94538
        • Arcutis Biotherapeutics Clinical Site 19
      • Santa Monica, California, United States, 90404
        • Arcutis Biotherapeutics Clinical Site 21
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Arcutis Biotherapeutics Clinical Site 42
      • Miami, Florida, United States, 33144
        • Arcutis Biotherapeutics Clinical Site 24
      • Tampa, Florida, United States, 33613
        • Arcutis Biotherapeutics Clinical Site 12
    • Illinois
      • Rolling Meadows, Illinois, United States, 60008
        • Arcutis Biotherapeutics Clinical Site 10
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • Arcutis Biotherapeutics Clinical Site 22
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Arcutis Biotherapeutics Clinical Site 15
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Arcutis Biotherapeutics Clinical Site 28
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Arcutis Biotherapeutics Clinical Site 40
      • Detroit, Michigan, United States, 48202
        • Arcutis Biotherapeutics Clinical Site 20
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Arcutis Biotherapeutics Clinical Site 14
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Arcutis Biotherapeutics Clinical Site 23
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Arcutis Biotherapeutics Clinical Site 18
    • Oregon
      • Portland, Oregon, United States, 97210
        • Arcutis Biotherapeutics Clinical Site 29
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Arcutis Biotherapeutics Clinical Site 27
    • Texas
      • Arlington, Texas, United States, 76011
        • Arcutis Biotherapeutics Clinical Site 13
      • Austin, Texas, United States, 78759
        • Arcutis Biotherapeutics Clinical Site 11
      • College Station, Texas, United States, 77845
        • Arcutis Biotherapeutics Clinical Site 41
      • Houston, Texas, United States, 77056
        • Arcutis Biotherapeutics Clinical Site 25
      • Pflugerville, Texas, United States, 78660
        • Arcutis Biotherapeutics Clinical Site 26
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Arcutis Biotherapeutics Clinical Site 17

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants legally competent to sign and give informed consent.
  2. Males and females ages 18 years and older (inclusive) at the time of consent.
  3. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
  4. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas.
  5. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Baseline.
  6. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
  7. 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).
  8. Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
  9. Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
  10. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Exclusion Criteria:

  1. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
  2. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
  3. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study.
  4. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
  5. Subjects with PHQ-8 ≥10 at Screening or Baseline visits.
  6. Previous treatment with ARQ-151 and ARQ-154.
  7. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks.
  8. Known allergies to excipients in ARQ-154 foam.
  9. Known or suspected: severe renal insufficiency or moderate to severe hepatic disorders; hypersensitivity to component(s) of the investigational products; or history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current.
  10. Subjects with a history of a major surgery within 8 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
  11. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
  12. Subjects unable to apply product to the scalp due to physical limitations.
  13. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  14. A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.
  15. Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
  16. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects.
  17. Any condition that in the Investigator's assessment would preclude the subject from participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Roflumilast Foam 0.3%
Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks.
Drug: Roflumilast Foam 0.3%
Roflumilast foam for topical application.
Other Names:
  • ARQ-154
Placebo Comparator: Vehicle Foam
Participants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks.
Drug: Vehicle foam
Vehicle foam for topical application.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Achievement of Investigator Global Assessment (IGA) Success at Week 8
Time Frame: Week 8
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 observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Achievement of IGA Success at Weeks 2 and 4
Time Frame: Weeks 2 and 4
The number of participants achieving "success" in IGA assessment of disease severity at Weeks 2 and 4 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 observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Weeks 2 and 4
Change From Baseline in Overall Assessment of Erythema Score
Time Frame: Weeks 2, 4, and 8
The mean (SD) change from baseline in Overall Assessment of Erythema score at Weeks 2, 4, and 8 is shown. The Erythema Assessment is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("None: no evidence of erythema.") to 3 ("Severe: Intense [fiery red] erythema."). Higher scores indicate greater severity.
Weeks 2, 4, and 8
Achievement of Overall Assessment of Erythema Success
Time Frame: Weeks 2, 4, and 8
The number of participants achieving "success" in Overall Assessment of Erythema at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an overall score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Erythema is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("None: no evidence of erythema.") to 3 ("Severe: Intense [fiery red] erythema."). Higher scores indicate greater severity.
Weeks 2, 4, and 8
Change From Baseline in Overall Assessment of Scaling Score
Time Frame: Weeks 2, 4, and 8
The mean (SD) change from baseline in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is shown. The Overall Assessment of Scaling is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("No scaling: No scaling evident on lesions.") to 3 ("Severe: Coarse, thick scales, with flaking into clothes or skin."). Higher scores indicate greater severity.
Weeks 2, 4, and 8
Achievement of Overall Assessment of Scaling Success
Time Frame: Weeks 2, 4, and 8
The number of participants achieving "success" in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an Overall Assessment of Scaling score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Scaling is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("No scaling: No scaling evident on lesions.") to 3 ("Severe: Coarse, thick scales, with flaking into clothes or skin."). Higher scores indicate greater severity.
Weeks 2, 4, and 8
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Time Frame: Weeks 2, 4, and 8
The change from baseline in WI-NRS is shown. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Negative values represent a decrease in worst itch from baseline, and positive values indicate an increase.
Weeks 2, 4, and 8
Achievement of WI-NRS Success
Time Frame: Weeks 2, 4, and 8
The number of participants achieving WI-NRS "success" at Weeks 2, 4, and 8 is presented. Success was defined as achievement of a ≥4-point improvement from baseline WI-NRS score. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.
Weeks 2, 4, and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arcutis Biotherapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Berk, MD, Arcutis Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARQ-154-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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