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

Seborrheic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091646
• Other study ID #: ARQ-154-203
• Status: Completed
• Phase: Phase 2
• Start date: December 4, 2019
• Est. completion date: August 21, 2020

Study information

• Verified date: June 2023
• Source: Arcutis Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: August 21, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Seborrheic Dermatitis

Intervention

Drug:
• Roflumilast Foam 0.3%
Roflumilast foam for topical application.
• Vehicle foam
Vehicle foam for topical application.

Locations

Country	Name	City	State
Canada	Arcutis Biotherapeutics Clinical Site 31	Markham	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 30	Windsor	Ontario
United States	Arcutis Biotherapeutics Clinical Site 13	Arlington	Texas
United States	Arcutis Biotherapeutics Clinical Site 11	Austin	Texas
United States	Arcutis Biotherapeutics Clinical Site 18	Bexley	Ohio
United States	Arcutis Biotherapeutics Clinical Site 40	Clinton Township	Michigan
United States	Arcutis Biotherapeutics Clinical Site 41	College Station	Texas
United States	Arcutis Biotherapeutics Clinical Site 42	Coral Gables	Florida
United States	Arcutis Biotherapeutics Clinical Site 20	Detroit	Michigan
United States	Arcutis Biotherapeutics Clinical Site 19	Fremont	California
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 25	Houston	Texas
United States	Arcutis Biotherapeutics Clinical Site 15	Louisville	Kentucky
United States	Arcutis Biotherapeutics Clinical Site 24	Miami	Florida
United States	Arcutis Biotherapeutics Clinical Site 17	Norfolk	Virginia
United States	Arcutis Biotherapeutics Clinical Site 26	Pflugerville	Texas
United States	Arcutis Biotherapeutics Clinical Site 27	Pittsburgh	Pennsylvania
United States	Arcutis Biotherapeutics Clinical Site 22	Plainfield	Indiana
United States	Arcutis Biotherapeutics Clinical Site 29	Portland	Oregon
United States	Arcutis Biotherapeutics Clinical Site 28	Rockville	Maryland
United States	Arcutis Biotherapeutics Clinical Site 10	Rolling Meadows	Illinois
United States	Arcutis Biotherapeutics Clinical Site 21	Santa Monica	California
United States	Arcutis Biotherapeutics Clinical Site 12	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Arcutis Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Achievement of IGA Success at 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
Secondary	Change From Baseline in Overall Assessment of Erythema Score	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
Secondary	Achievement of Overall Assessment of Erythema Success	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
Secondary	Change From Baseline in Overall Assessment of Scaling Score	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
Secondary	Achievement of Overall Assessment of Scaling Success	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
Secondary	Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score	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
Secondary	Achievement of WI-NRS Success	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