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Trial of PDE4 Inhibition With Roflumilast for the Management of Seborrheic Dermatitis (STRATUM)

Primary Purpose

Seborrheic Dermatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ARQ-154 - Active
ARQ-154 Vehicle
Sponsored by
Arcutis Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arcutis Biotherapeutics Clinical Site 01
  • Arcutis Biotherapeutics Clinical Site 45
  • Arcutis Biotherapeutics Clinical Site 46
  • Arcutis Biotherapeutics Clinical Site 64
  • Arcutis Biotherapeutics Clinical Site 21
  • Arcutis Biotherapeutics Clinical Site 42
  • Arcutis Biotherapeutics Clinical Site 57
  • Arcutis Biotherapeutics Clinical Site 33
  • Arcutis Biotherapeutics Clinical Site 31
  • Arcutis Biotherapeutics Clinical Site 65
  • Arcutis Biotherapeutics Clinical Site 12
  • Arcutis Biotherapeutics Clinical Site 10
  • Arcutis Biotherapeutics Clinical Site 03
  • Arcutis Biotherapeutics Clinical Site 22
  • Arcutis Biotherapeutics Clinical Site 15
  • Arcutis Biotherapeutics Clinical Site 04
  • Arcutis Biotherapeutics Clinical Site 02
  • Arcutis Biotherapeutics Clinical Site 28
  • Arcutis Biotherapeutics Clinical Site 40
  • Arcutis Biotherapeutics Clinical Site 20
  • Arcutis Biotherapeutics Clinical Site 14
  • Arcutis Biotherapeutics Clinical Site 44
  • Arcutis Biotherapeutics Clinical Site 19
  • Arcutis Biotherapeutics Clinical Site 34
  • Arcutis Biotherapeutics Clinical Site 63
  • Arcutis Biotherapeutics Clinical Site 66
  • Arcutis Biotherapeutics Clinical Site 23
  • Arcutis Biotherapeutics Clinical Site 70
  • Arcutis Biotherapeutics Clinical Site 18
  • Arcutis Biotherapeutics Clinical Site 71
  • Arcutis Biotherapeutics Clinical Site 08
  • Arcutis Biotherapeutics Clinical Site 27
  • Arcutis Biotherapeutics Clinical Site 06
  • Arcutis Biotherapeutics Clinical Site 13
  • Arcutis Biotherapeutics Clinical Site 11
  • Arcutis Biotherapeutics Clinical Site 41
  • Arcutis Biotherapeutics Clinical Site 60
  • Arcutis Biotherapeutics Clinical Site 26
  • Arcutis Biotherapeutics Clinical Site 72
  • Arcutis Biotherapeutics Clinical Site 54
  • Arcutis Biotherapeutics Clinical Site 24
  • Arcutis Biotherapeutics Clinical Site 07
  • Arcutis Biotherapeutics Clinical Site 17
  • Arcutis Biotherapeutics Clinical Site 35
  • Arcutis Biotherapeutics Clinical Site 37
  • Arcutis Biotherapeutics Clinical Site 47
  • Arcutis Biotherapeutics Clinical Site 43
  • Arcutis Biotherapeutics Clinical Site 16
  • Arcutis Biotherapeutics Clinical Site 29
  • Arcutis Biotherapeutics Clinical Site 30
  • Arcutis Biotherapeutics Clinical Site 32
  • Arcutis Biotherapeutics Clinical Site 36
  • Arcutis Biotherapeutics Clinical Site 09

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental: ARQ-154 Foam 0.3%

Placebo Comparator: ARQ-154 Vehicle Foam

Arm Description

Outcomes

Primary Outcome Measures

Investigator Global Assessment Scale (IGA) Score Change
IGA Success, defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

Secondary Outcome Measures

In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline.
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline.
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline.
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
IGA Success
This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
Overall Assessment of Scaling Score
Achievement of an Overall Assessment of Scaling score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).
Overall Assessment of Erythema Score
Achievement of an Overall Assessment of Erythema score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).
Investigator Global Assessment Scale (IGA) Score Change
Achievement of an IGA score of 'clear'. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
IGA Success
This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

Full Information

First Posted
July 13, 2021
Last Updated
March 7, 2023
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04973228
Brief Title
Trial of PDE4 Inhibition With Roflumilast for the Management of Seborrheic Dermatitis (STRATUM)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
April 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcutis Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will assess the safety and efficacy of ARQ-154 foam vs vehicle applied once for 8 weeks by subjects with seborrheic dermatitis.
Detailed Description
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily for 8 weeks to subjects with seborrheic dermatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: ARQ-154 Foam 0.3%
Arm Type
Active Comparator
Arm Title
Placebo Comparator: ARQ-154 Vehicle Foam
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARQ-154 - Active
Intervention Description
ARQ-154 Foam 0.3% - Active
Intervention Type
Drug
Intervention Name(s)
ARQ-154 Vehicle
Intervention Description
ARQ-154 Foam - Vehicle
Primary Outcome Measure Information:
Title
Investigator Global Assessment Scale (IGA) Score Change
Description
IGA Success, defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline.
Description
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Week 8
Title
In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline.
Description
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Week 4
Title
In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline.
Description
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Week 2
Title
IGA Success
Description
This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
Time Frame
Week 4
Title
Overall Assessment of Scaling Score
Description
Achievement of an Overall Assessment of Scaling score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).
Time Frame
Week 8
Title
Overall Assessment of Erythema Score
Description
Achievement of an Overall Assessment of Erythema score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).
Time Frame
Week 8
Title
Investigator Global Assessment Scale (IGA) Score Change
Description
Achievement of an IGA score of 'clear'. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
Time Frame
Week 8
Title
IGA Success
Description
This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
Time Frame
Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Berk, MD
Organizational Affiliation
Arcutis Biotherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arcutis Biotherapeutics Clinical Site 01
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 45
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 46
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 64
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 21
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 42
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 57
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 33
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 31
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 65
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 12
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 10
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 03
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 22
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 15
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 04
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 02
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 28
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 40
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 20
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 14
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 44
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 19
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 34
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 63
City
Bronx
State/Province
New York
ZIP/Postal Code
10462
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 66
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 23
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 70
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 18
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 71
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 08
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 27
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 06
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 13
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 11
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 41
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 60
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 26
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 72
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 54
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 24
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 07
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 17
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Arcutis Biotherapeutics Clinical Site 35
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 37
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 47
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 43
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 16
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 29
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 30
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 32
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 36
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Arcutis Biotherapeutics Clinical Site 09
City
Westmount
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Trial of PDE4 Inhibition With Roflumilast for the Management of Seborrheic Dermatitis (STRATUM)

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