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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04973228
Other study ID # ARQ-154-304
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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