Clincosm LogoSign in Get a demo

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

Sponsor
Arcutis Biotherapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04973228
Collaborator
(none)
457
Enrollment
53
Locations
2
Arms
8.9
Actual Duration (Months)
8.6
Patients Per Site
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ARQ-154 - Active
  • Drug: ARQ-154 Vehicle
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
457 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 8, 2021
Actual Primary Completion Date :
Apr 6, 2022
Actual Study Completion Date :
Apr 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Experimental: ARQ-154 Foam 0.3%

Drug: ARQ-154 - Active
ARQ-154 Foam 0.3% - Active
Placebo Comparator: Placebo Comparator: ARQ-154 Vehicle Foam

Drug: ARQ-154 Vehicle
ARQ-154 Foam - Vehicle

Outcome Measures

Primary Outcome Measures

  1. Investigator Global Assessment Scale (IGA) Score Change [Week 8]

    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

  1. In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. [Week 8]

    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").

  2. In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. [Week 4]

    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").

  3. In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. [Week 2]

    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").

  4. IGA Success [Week 4]

    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).

  5. Overall Assessment of Scaling Score [Week 8]

    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).

  6. Overall Assessment of Erythema Score [Week 8]

    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).

  7. Investigator Global Assessment Scale (IGA) Score Change [Week 8]

    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).

  8. IGA Success [Week 2]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arcutis Biotherapeutics Clinical Site 01 Scottsdale Arizona United States 85255
2 Arcutis Biotherapeutics Clinical Site 45 Encinitas California United States 92024
3 Arcutis Biotherapeutics Clinical Site 46 San Diego California United States 92123
4 Arcutis Biotherapeutics Clinical Site 64 San Diego California United States 92123
5 Arcutis Biotherapeutics Clinical Site 21 Santa Monica California United States 90404
6 Arcutis Biotherapeutics Clinical Site 42 Coral Gables Florida United States 33134
7 Arcutis Biotherapeutics Clinical Site 57 Delray Beach Florida United States 33484
8 Arcutis Biotherapeutics Clinical Site 33 Largo Florida United States 33770
9 Arcutis Biotherapeutics Clinical Site 31 North Miami Beach Florida United States 33162
10 Arcutis Biotherapeutics Clinical Site 65 Sanford Florida United States 32771
11 Arcutis Biotherapeutics Clinical Site 12 Tampa Florida United States 33613
12 Arcutis Biotherapeutics Clinical Site 10 Rolling Meadows Illinois United States 60008
13 Arcutis Biotherapeutics Clinical Site 03 Indianapolis Indiana United States 46250
14 Arcutis Biotherapeutics Clinical Site 22 Plainfield Indiana United States 46168
15 Arcutis Biotherapeutics Clinical Site 15 Louisville Kentucky United States 40217
16 Arcutis Biotherapeutics Clinical Site 04 Lake Charles Louisiana United States 70605
17 Arcutis Biotherapeutics Clinical Site 02 Rockville Maryland United States 20850
18 Arcutis Biotherapeutics Clinical Site 28 Rockville Maryland United States 20850
19 Arcutis Biotherapeutics Clinical Site 40 Clinton Township Michigan United States 48038
20 Arcutis Biotherapeutics Clinical Site 20 Detroit Michigan United States 48202
21 Arcutis Biotherapeutics Clinical Site 14 Fridley Minnesota United States 55432
22 Arcutis Biotherapeutics Clinical Site 44 Saint Joseph Missouri United States 64506
23 Arcutis Biotherapeutics Clinical Site 19 Reno Nevada United States 89509
24 Arcutis Biotherapeutics Clinical Site 34 East Windsor New Jersey United States 08520
25 Arcutis Biotherapeutics Clinical Site 63 Bronx New York United States 10462
26 Arcutis Biotherapeutics Clinical Site 66 New York New York United States 10065
27 Arcutis Biotherapeutics Clinical Site 23 High Point North Carolina United States 27262
28 Arcutis Biotherapeutics Clinical Site 70 Winston-Salem North Carolina United States 27104
29 Arcutis Biotherapeutics Clinical Site 18 Bexley Ohio United States 43209
30 Arcutis Biotherapeutics Clinical Site 71 Portland Oregon United States 97223
31 Arcutis Biotherapeutics Clinical Site 08 Broomall Pennsylvania United States 19008
32 Arcutis Biotherapeutics Clinical Site 27 Pittsburgh Pennsylvania United States 15213
33 Arcutis Biotherapeutics Clinical Site 06 Knoxville Tennessee United States 37922
34 Arcutis Biotherapeutics Clinical Site 13 Arlington Texas United States 76011
35 Arcutis Biotherapeutics Clinical Site 11 Austin Texas United States 78759
36 Arcutis Biotherapeutics Clinical Site 41 College Station Texas United States 77845
37 Arcutis Biotherapeutics Clinical Site 60 Houston Texas United States 77030
38 Arcutis Biotherapeutics Clinical Site 26 Pflugerville Texas United States 78660
39 Arcutis Biotherapeutics Clinical Site 72 Plano Texas United States 75024
40 Arcutis Biotherapeutics Clinical Site 54 San Antonio Texas United States 78213
41 Arcutis Biotherapeutics Clinical Site 24 San Antonio Texas United States 78218
42 Arcutis Biotherapeutics Clinical Site 07 West Jordan Utah United States 84088
43 Arcutis Biotherapeutics Clinical Site 17 Norfolk Virginia United States 23502
44 Arcutis Biotherapeutics Clinical Site 35 Calgary Alberta Canada T2J 7E1
45 Arcutis Biotherapeutics Clinical Site 37 Surrey British Columbia Canada V3V 0C6
46 Arcutis Biotherapeutics Clinical Site 47 Winnipeg Manitoba Canada R3M 3Z4
47 Arcutis Biotherapeutics Clinical Site 43 Fredericton New Brunswick Canada E3B 1G9
48 Arcutis Biotherapeutics Clinical Site 16 London Ontario Canada N6H 5L5
49 Arcutis Biotherapeutics Clinical Site 29 Mississauga Ontario Canada L5H 1G9
50 Arcutis Biotherapeutics Clinical Site 30 North Bay Ontario Canada P1B 3Z7
51 Arcutis Biotherapeutics Clinical Site 32 Peterborough Ontario Canada K9J 5K2
52 Arcutis Biotherapeutics Clinical Site 36 Waterloo Ontario Canada N2J 1C4
53 Arcutis Biotherapeutics Clinical Site 09 Westmount Quebec Canada H3Z 2S6

Sponsors and Collaborators

  • Arcutis Biotherapeutics, Inc.

Investigators

  • Study Director: David Berk, MD, Arcutis Biotherapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04973228
Other Study ID Numbers:
  • ARQ-154-304
First Posted:
Jul 22, 2021
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic

Study Results

No Results Posted as of Aug 8, 2022