Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

Seborrheic Dermatitis Clinical Trial

Official title:

A Phase 3, 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: NCT04973228
• Other study ID #: ARQ-154-304
• Status: Completed
• Phase: Phase 3
• Start date: July 8, 2021
• Est. completion date: April 6, 2022

Study information

• Verified date: February 2024
• Source: Arcutis Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Key Inclusion Criteria:

• Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.

• Males and females ages 9 years and older at the time of consent.

• Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.

• Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.

• An Investigator Global Assessment (IGA) 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.

• Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Key Exclusion Criteria:

• Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.

• Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.

• Previous treatment with ARQ-154 or ARQ-151.

• Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.

• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

• Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.

• Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).

• Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Seborrheic Dermatitis

Intervention

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

Locations

Country	Name	City	State
Canada	Arcutis Biotherapeutics Clinical Site 35	Calgary	Alberta
Canada	Arcutis Biotherapeutics Clinical Site 43	Fredericton	New Brunswick
Canada	Arcutis Biotherapeutics Clinical Site 16	London	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 29	Mississauga	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 30	North Bay	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 32	Peterborough	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 37	Surrey	British Columbia
Canada	Arcutis Biotherapeutics Clinical Site 36	Waterloo	Ontario
Canada	Arcutis Biotherapeutics Clinical Site 09	Westmount	Quebec
Canada	Arcutis Biotherapeutics Clinical Site 47	Winnipeg	Manitoba
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 63	Bronx	New York
United States	Arcutis Biotherapeutics Clinical Site 08	Broomall	Pennsylvania
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 57	Delray Beach	Florida
United States	Arcutis Biotherapeutics Clinical Site 20	Detroit	Michigan
United States	Arcutis Biotherapeutics Clinical Site 34	East Windsor	New Jersey
United States	Arcutis Biotherapeutics Clinical Site 45	Encinitas	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 60	Houston	Texas
United States	Arcutis Biotherapeutics Clinical Site 03	Indianapolis	Indiana
United States	Arcutis Biotherapeutics Clinical Site 06	Knoxville	Tennessee
United States	Arcutis Biotherapeutics Clinical Site 04	Lake Charles	Louisiana
United States	Arcutis Biotherapeutics Clinical Site 33	Largo	Florida
United States	Arcutis Biotherapeutics Clinical Site 15	Louisville	Kentucky
United States	Arcutis Biotherapeutics Clinical Site 66	New York	New York
United States	Arcutis Biotherapeutics Clinical Site 17	Norfolk	Virginia
United States	Arcutis Biotherapeutics Clinical Site 31	North Miami Beach	Florida
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 72	Plano	Texas
United States	Arcutis Biotherapeutics Clinical Site 71	Portland	Oregon
United States	Arcutis Biotherapeutics Clinical Site 19	Reno	Nevada
United States	Arcutis Biotherapeutics Clinical Site 02	Rockville	Maryland
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 44	Saint Joseph	Missouri
United States	Arcutis Biotherapeutics Clinical Site 24	San Antonio	Texas
United States	Arcutis Biotherapeutics Clinical Site 54	San Antonio	Texas
United States	Arcutis Biotherapeutics Clinical Site 46	San Diego	California
United States	Arcutis Biotherapeutics Clinical Site 64	San Diego	California
United States	Arcutis Biotherapeutics Clinical Site 65	Sanford	Florida
United States	Arcutis Biotherapeutics Clinical Site 21	Santa Monica	California
United States	Arcutis Biotherapeutics Clinical Site 01	Scottsdale	Arizona
United States	Arcutis Biotherapeutics Clinical Site 12	Tampa	Florida
United States	Arcutis Biotherapeutics Clinical Site 07	West Jordan	Utah
United States	Arcutis Biotherapeutics Clinical Site 70	Winston-Salem	North Carolina

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 Success on the Investigator Global Assessment (IGA) at Week 8	The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') [higher scores indicating greater severity].	Week 8
Secondary	Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8	The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of =4, "success" is defined as achievement of a =4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 8.	Week 8
Secondary	Achievement of Success in the WI-NRS at Week 4	The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of =4, "success" is defined as achievement of a =4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 4.	Week 4
Secondary	Achievement of Success in the WI-NRS at Week 2	The percentage of participants achieving WI-NRS "success" is presented. In participants with a weekly average baseline pruritus score of =4, "success" is defined as achievement of a =4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2. The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity).	Week 2
Secondary	Achievement of Success on the IGA at Week 2	The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of =4, "success" is defined as achievement of a =4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2.	Week 2
Secondary	Achievement of Success on the IGA at Week 4	The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') [higher scores indicating greater severity].	Week 4
Secondary	Achievement of Overall Assessment of Scaling Score of 0 at Week 8	The percentage of participants achieving Overall Assessment of Scaling score of 0 at Week 8 is presented. 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 symptom severity.	Week 8
Secondary	Achievement of Overall Assessment of Erythema Score of 0 at Week 8	The percentage of participants achieving Overall Assessment of Erythema score of 0 at Week 8 is presented. 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.	Week 8