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

NCT04091646 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ARQ-154-203
• Study Type: interventional
• Target: 226
• Locations: 2 countries
• Sites: 24

Brief 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.

Conditions

Seborrheic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Achievement of Investigator Global Assessment (IGA) Success at 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 Outcomes (7)

• Achievement of IGA Success at Weeks 2 and 4

  Weeks 2 and 4

• Change From Baseline in Overall Assessment of Erythema Score

  Weeks 2, 4, and 8

• Achievement of Overall Assessment of Erythema Success

  Weeks 2, 4, and 8

• Change From Baseline in Overall Assessment of Scaling Score

  Weeks 2, 4, and 8

• Achievement of Overall Assessment of Scaling Success

  Weeks 2, 4, and 8

Study Arms (2)

Roflumilast Foam 0.3%

ACTIVE COMPARATOR

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%

Vehicle Foam

PLACEBO COMPARATOR

Participants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks.

Drug: Vehicle foam

Interventions

Roflumilast Foam 0.3% DRUG

Roflumilast foam for topical application.

Also known as: ARQ-154

Roflumilast Foam 0.3%

Vehicle foam DRUG

Vehicle foam for topical application.

Also known as: Placebo

Vehicle Foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants legally competent to sign and give informed consent.
• Males and females ages 18 years and older (inclusive) at the time of consent.
• Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
• Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas.
• An Investigator Global Assessment (IGA) of 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, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
• Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

You may not qualify if:

• 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.
• Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
• 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.
• 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.
• Subjects with PHQ-8 ≥10 at Screening or Baseline visits.
• Previous treatment with ARQ-151 and ARQ-154.
• Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks.
• Known allergies to excipients in ARQ-154 foam.
• 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.
• 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.
• Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• Subjects unable to apply product to the scalp due to physical limitations.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.
• 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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (24)

Arcutis Biotherapeutics Clinical Site 19

Fremont, California, 94538, United States

Location

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, 90404, United States

Location

Arcutis Biotherapeutics Clinical Site 42

Coral Gables, Florida, 33134, United States

Location

Arcutis Biotherapeutics Clinical Site 24

Miami, Florida, 33144, United States

Location

Arcutis Biotherapeutics Clinical Site 12

Tampa, Florida, 33613, United States

Location

Arcutis Biotherapeutics Clinical Site 10

Rolling Meadows, Illinois, 60008, United States

Location

Arcutis Biotherapeutics Clinical Site 22

Plainfield, Indiana, 46168, United States

Location

Arcutis Biotherapeutics Clinical Site 15

Louisville, Kentucky, 40217, United States

Location

Arcutis Biotherapeutics Clinical Site 28

Rockville, Maryland, 20850, United States

Location

Arcutis Biotherapeutics Clinical Site 40

Clinton Township, Michigan, 48038, United States

Location

Arcutis Biotherapeutics Clinical Site 20

Detroit, Michigan, 48202, United States

Location

Arcutis Biotherapeutics Clinical Site 14

Fridley, Minnesota, 55432, United States

Location

Arcutis Biotherapeutics Clinical Site 23

High Point, North Carolina, 27262, United States

Location

Arcutis Biotherapeutics Clinical Site 18

Bexley, Ohio, 43209, United States

Location

Arcutis Biotherapeutics Clinical Site 29

Portland, Oregon, 97210, United States

Location

Arcutis Biotherapeutics Clinical Site 27

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Biotherapeutics Clinical Site 13

Arlington, Texas, 76011, United States

Location

Arcutis Biotherapeutics Clinical Site 11

Austin, Texas, 78759, United States

Location

Arcutis Biotherapeutics Clinical Site 41

College Station, Texas, 77845, United States

Location

Arcutis Biotherapeutics Clinical Site 25

Houston, Texas, 77056, United States

Location

Arcutis Biotherapeutics Clinical Site 26

Pflugerville, Texas, 78660, United States

Location

Arcutis Biotherapeutics Clinical Site 17

Norfolk, Virginia, 23502, United States

Location

Arcutis Biotherapeutics Clinical Site 31

Markham, Ontario, L3P 1X2, Canada

Location

Arcutis Biotherapeutics Clinical Site 30

Windsor, Ontario, N8W 1E6, Canada

Location

Related Publications (1)

• Zirwas MJ, Draelos ZD, DuBois J, Kircik LH, Moore AY, Stein Gold L, Alonso-Llamazares J, Bukhalo M, Bruce S, Eads K, Green LJ, Guenthner ST, Ferris LK, Forman SB, Kempers SE, Lain E, Lynde CW, Pariser DM, Toth DP, Yamauchi PS, Higham RC, Krupa D, Burnett P, Berk DR. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):613-620. doi: 10.1001/jamadermatol.2023.0846.

  PMID: 37133856 DERIVED

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: December 4, 2019
• Primary Completion: August 18, 2020
• Study Completion: August 21, 2020
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (22); CA (2)