Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

NCT04445987 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ARQ-154-214
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 39

Brief Summary

This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.

Conditions

Seborrheic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With ≥1 Adverse Event (AE)

  The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.

  Up to 52 weeks

• Number of Participants With ≥1 Serious Adverse Event (SAE)

  The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.

  Up to 52 weeks

Secondary Outcomes (4)

• Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear

  Weeks 4, 12, 24, 36, and 52

• Achievement of IGA Success

  Weeks 4, 12, 24, 36, and 52

• Duration of IGA Success

  Weeks 4, 12, 24, 36, and 52

• IGA Treatment-Free Interval

  Weeks 4, 12, 24, 36, and 52

Study Arms (1)

Long-term safety of ARQ-154

EXPERIMENTAL

Open-label, Long-term Safety of ARQ-154

Drug: ARQ-154

Interventions

ARQ-154 DRUG

ARQ-154 foam 0.3% applied once daily for 52 weeks

Long-term safety of ARQ-154

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants legally competent to sign and give informed consent or (for adolescents) assent.
• Males and females ages 9 years and older (inclusive) at the time of consent.
• Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
• Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
• Cohort 1 only:
• Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study.
• Cohort 2 subjects that have not participated in a prior ARQ-154 study:
• 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 up to ≤20% BSA involvement.
• An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.
• Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day 1.
• Cohort 2 subjects that have participated in a prior ARQ-154 study:
• Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
• Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.

You may not qualify if:

• Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
• Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• Subjects unable to apply investigational product to the scalp due to physical limitation.
• Known allergies to excipients in ARQ-154 foam.
• 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 during the study period.
• Known or suspected:
• severe renal insufficiency or moderate to severe hepatic disorders
• history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
• Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
• Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
• 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.
• Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members that live in the same household of enrolled subjects.
• Cohort 1 only:

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (39)

Arcutis Biotherapeutics Clinical Site 59

Beverly Hills, California, 90212, United States

Location

Arcutis Biotherapeutics Clinical Site 51

Encino, California, 91436, United States

Location

Arcutis Biotherapeutics Clinical Site 75

Fountain Valley, California, 92708, United States

Location

Arcutis Biotherapeutics Clinical Site 19

Fremont, California, 94538, United States

Location

Arcutis Biotherapeutics Clinical Site 62

Los Angeles, California, 90036, United States

Location

Arcutis Biotherapeutics Clinical Site 64

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, 90404, United States

Location

Arcutis Biotherapeutics Clinical Site 53

Aventura, Florida, 33180, United States

Location

Arcutis Biotherapeutics Clinical Site 42

Coral Gables, Florida, 33134, United States

Location

Arcutis Biotherapeutics Clinical Site 57

Delray Beach, Florida, 33484, United States

Location

Arcutis Biotherapeutics Clinical Site 24

Miami, Florida, 33144, United States

Location

Arcutis Biotherapeutics Clinical Site 65

Sanford, Florida, 32771, 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 52

Metairie, Louisiana, 70006, United States

Location

Arcutis Biotherapeutics Clinical Site 28

Rockville, Maryland, 20850, United States

Location

Arcutis Biotherapeutics Clinical Site 73

Brighton, Massachusetts, 02135, 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 58

Fort Gratiot, Michigan, 48059, United States

Location

Arcutis Biotherapeutics Clinical Site 14

Fridley, Minnesota, 55432, United States

Location

Arcutis Biotherapeutics Clinical Site 50

Las Vegas, Nevada, 89148, United States

Location

Arcutis Biotherapeutics Clinical Site 56

Portsmouth, New Hampshire, 03801, United States

Location

Arcutis Biotherapeutics Clinical Site 55

New York, New York, 10029, United States

Location

Arcutis Biotherapeutics Clinical Site 63

The Bronx, New York, 10462, 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 76

Charleston, South Carolina, 29407, 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 54

San Antonio, Texas, 78213, United States

Location

Arcutis Biotherapeutics Clinical Site 17

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

• Alexis AF, Bukhalo M, Cook-Bolden FE, Del Rosso JQ, Draelos ZD, DuBois JC, Ferris LK, Forman SB, Kempers SE, Kircik LH, Lain E, Moore AY, Pariser DM, Raoof J, Zirwas MJ, Seal MS, Kato S, Chu DH, Krupa D, Snyder S, Burnett P, Berk DR. Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks. Am J Clin Dermatol. 2026 Jan;27(1):189-198. doi: 10.1007/s40257-025-00984-2. Epub 2025 Nov 1.

  PMID: 41175336 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

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: June 12, 2020
• Primary Completion: November 19, 2022
• Study Completion: November 19, 2022
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (39)