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Completed

NCT Number: NCT04973228

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

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.

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Key information

Conditions

Seborrheic Dermatitis Dermatitis Dermatitis, Seborrheic Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arcutis Biotherapeutics Clinical Site 35, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Roflumilast Foam

Drug

Roflumilast 0.3% foam for topical application

Other names: ARQ-154

Vehicle Foam

Drug

Vehicle foam for topical application

Primary outcomes

  1. Achievement of Success on the Investigator Global Assessment (IGA) at Week 8

    Time frame: 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].

Secondary outcomes

  1. Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8

    Time frame: 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.

  2. Achievement of Success in the WI-NRS at Week 4

    Time frame: 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.

  3. Achievement of Success in the WI-NRS at Week 2

    Time frame: 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).

  4. Achievement of Success on the IGA at Week 2

    Time frame: 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.

  5. Achievement of Success on the IGA at Week 4

    Time frame: 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].

  6. Achievement of Overall Assessment of Scaling Score of 0 at Week 8

    Time frame: 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.

  7. Achievement of Overall Assessment of Erythema Score of 0 at Week 8

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Arcutis Biotherapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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