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

NCT ID: NCT04091646

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-04
• Study Completion Date: 2020-08-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Roflumilast Foam 0.3%

Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Roflumilast Foam 0.3%

Intervention Type: DRUG

Roflumilast foam for topical application.

Vehicle Foam

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

Group Type: PLACEBO_COMPARATOR

Vehicle foam

Intervention Type: DRUG

Vehicle foam for topical application.

Interventions

Roflumilast Foam 0.3%

Roflumilast foam for topical application.

Intervention Type: DRUG

Vehicle foam

Vehicle foam for topical application.

Intervention Type: DRUG

Other Intervention Names

ARQ-154; Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Berk, MD

Role: STUDY_DIRECTOR

Arcutis Biotherapeutics, Inc.

Locations

Arcutis Biotherapeutics Clinical Site 19

Fremont, California, United States

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, United States

Arcutis Biotherapeutics Clinical Site 42

Coral Gables, Florida, United States

Arcutis Biotherapeutics Clinical Site 24

Miami, Florida, United States

Arcutis Biotherapeutics Clinical Site 12

Tampa, Florida, United States

Arcutis Biotherapeutics Clinical Site 10

Rolling Meadows, Illinois, United States

Arcutis Biotherapeutics Clinical Site 22

Plainfield, Indiana, United States

Arcutis Biotherapeutics Clinical Site 15

Louisville, Kentucky, United States

Arcutis Biotherapeutics Clinical Site 28

Rockville, Maryland, United States

Arcutis Biotherapeutics Clinical Site 40

Clinton Township, Michigan, United States

Arcutis Biotherapeutics Clinical Site 20

Detroit, Michigan, United States

Arcutis Biotherapeutics Clinical Site 14

Fridley, Minnesota, United States

Arcutis Biotherapeutics Clinical Site 23

High Point, North Carolina, United States

Arcutis Biotherapeutics Clinical Site 18

Bexley, Ohio, United States

Arcutis Biotherapeutics Clinical Site 29

Portland, Oregon, United States

Arcutis Biotherapeutics Clinical Site 27

Pittsburgh, Pennsylvania, United States

Arcutis Biotherapeutics Clinical Site 13

Arlington, Texas, United States

Arcutis Biotherapeutics Clinical Site 11

Austin, Texas, United States

Arcutis Biotherapeutics Clinical Site 41

College Station, Texas, United States

Arcutis Biotherapeutics Clinical Site 25

Houston, Texas, United States

Arcutis Biotherapeutics Clinical Site 26

Pflugerville, Texas, United States

Arcutis Biotherapeutics Clinical Site 17

Norfolk, Virginia, United States

Arcutis Biotherapeutics Clinical Site 31

Markham, Ontario, Canada

Arcutis Biotherapeutics Clinical Site 30

Windsor, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 37133856 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ARQ-154-203

Identifier Type: -

Identifier Source: org_study_id