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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04973228
Recruitment Status : Completed
First Posted : July 22, 2021
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.

Study Description
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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
Seborrheic Dermatitis 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
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Study Type : Interventional  (Clinical Trial)
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 : July 8, 2021
Actual Primary Completion Date : April 6, 2022
Actual Study Completion Date : April 6, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Investigator Global Assessment Scale (IGA) Score Change [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04973228


Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
Investigators
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Study Director: David Berk, MD Arcutis Biotherapeutics, Inc.
More Information
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Responsible Party: Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04973228    
Other Study ID Numbers: ARQ-154-304
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Skin Diseases
 Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous