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

Phase 2

Completed

• Conditions: Seborrheic Dermatitis
• Interventions: Drug: Roflumilast Foam 0.3%; Drug: Vehicle foam

• Registration Number: NCT04091646
• Lead Sponsor: Arcutis Biotherapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Study Start: 2019-12-04
• Primary Completion: 2020-08-18
• Study Completion: 2020-08-21
• Disposition First Submitted: 2021-06-18
• Disposition First Submitted QC: 2021-06-18
• Disposition First Posted: 2021-06-23
• Status Verified: 2023-06
• Results First Submitted: 2023-06-12
• Results First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Results First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roflumilast Foam 0.3%	Roflumilast Foam 0.3%	Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks.
Vehicle Foam	Vehicle foam	Participants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Achievement of Investigator Global Assessment (IGA) Success at Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Overall Assessment of Scaling Score	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.
Achievement of Overall Assessment of Scaling Success	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.
Achievement of IGA Success at Weeks 2 and 4	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.
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score	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.
Change From Baseline in Overall Assessment of Erythema Score	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.
Achievement of Overall Assessment of Erythema Success	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.
Achievement of WI-NRS Success	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.

Trial Locations

Locations (24)

Arcutis Biotherapeutics Clinical Site 40; 🇺🇸 Clinton Township, Michigan, United States

Arcutis Biotherapeutics Clinical Site 29; 🇺🇸 Portland, Oregon, United States

Arcutis Biotherapeutics Clinical Site 11; 🇺🇸 Austin, Texas, United States

Arcutis Biotherapeutics Clinical Site 12; 🇺🇸 Tampa, Florida, United States

Arcutis Biotherapeutics Clinical Site 17; 🇺🇸 Norfolk, Virginia, United States

Arcutis Biotherapeutics Clinical Site 13; 🇺🇸 Arlington, Texas, United States

Arcutis Biotherapeutics Clinical Site 30; 🇨🇦 Windsor, Ontario, Canada

Arcutis Biotherapeutics Clinical Site 10; 🇺🇸 Rolling Meadows, Illinois, United States

Arcutis Biotherapeutics Clinical Site 18; 🇺🇸 Bexley, Ohio, United States

Arcutis Biotherapeutics Clinical Site 41; 🇺🇸 College Station, Texas, United States

Arcutis Biotherapeutics Clinical Site 26; 🇺🇸 Pflugerville, Texas, United States

Arcutis Biotherapeutics Clinical Site 27; 🇺🇸 Pittsburgh, Pennsylvania, United States

Arcutis Biotherapeutics Clinical Site 25; 🇺🇸 Houston, Texas, United States

Arcutis Biotherapeutics Clinical Site 19; 🇺🇸 Fremont, California, United States

Arcutis Biotherapeutics Clinical Site 42; 🇺🇸 Coral Gables, Florida, United States

Arcutis Biotherapeutics Clinical Site 21; 🇺🇸 Santa Monica, California, United States

Arcutis Biotherapeutics Clinical Site 24; 🇺🇸 Miami, Florida, United States

Arcutis Biotherapeutics Clinical Site 22; 🇺🇸 Plainfield, Indiana, United States

Arcutis Biotherapeutics Clinical Site 28; 🇺🇸 Rockville, Maryland, United States

Arcutis Biotherapeutics Clinical Site 20; 🇺🇸 Detroit, Michigan, United States

Arcutis Biotherapeutics Clinical Site 15; 🇺🇸 Louisville, Kentucky, 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 31; 🇨🇦 Markham, Ontario, Canada