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Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

Sponsor
Arcutis Biotherapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04091646
Collaborator
(none)
226
Enrollment
24
Locations
2
Arms
8.6
Actual Duration (Months)
9.4
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with seborrheic dermatitis

Condition or Disease Intervention/Treatment Phase
  • Drug: ARQ-154 foam 0.3%
  • Drug: ARQ-154 vehicle foam
 Phase 2

Detailed Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to subjects with seborrheic dermatitis.

Study Design

Study Type:
Interventional
Actual Enrollment :
226 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2b, 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 :
Dec 4, 2019
Actual Primary Completion Date :
Aug 18, 2020
Actual Study Completion Date :
Aug 21, 2020

Arms and Interventions

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

active

Drug: ARQ-154 foam 0.3%
experimental
Placebo Comparator: ARQ-154 foam Vehicle

placebo

Drug: ARQ-154 vehicle foam
experimental
Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Achievement of an IGA score of 'clear' or 'almost clear' plus a 2-grade improvement from Baseline. 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. IGA Score Change [Baseline, Week 2 and Week 4]

      Achievement of an IGA score of 'clear' or 'almost clear' plus a 2-grade improvement from Baseline at weeks 2 and 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).

    2. Overall Assessment of Erythema Score [Baseline, Week 2, Week 4, Week 8]

      Change from Baseline in Overall Assessment of Erythema score at each study visit. Achievement of an Overall Assessment of Erythema score of 0 or 1 plus a 2-grade improvement from Baseline. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).

    3. Overall Assessment of Scaling Score [Baseline, Week 2, Week 4, Week 8]

      Change from Baseline in Overall Assessment of Scaling score at each study visit. Achievement of an Overall Assessment of Scaling score of 0 or 1 plus a 2-grade improvement from Baseline. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).

    4. Worst Itch Numeric Rating Scale (WI-NRS) Score Change [Baseline, Week 2, Week 4, Week 8]

      Change in WI-NRS pruritus score from Baseline. In subjects with a Baseline WI-NRS pruritis score of > 4, 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")

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Participants legally competent to sign and give informed consent.

    2. Males and females ages 18 years and older (inclusive) at the time of consent.

    3. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.

    4. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas

    5. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Baseline.

    6. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.

    7. 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).

    8. Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.

    9. Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.

    10. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

    Exclusion Criteria:

    1. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study according to Excluded Medications and Treatments

    2. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED

    3. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study

    4. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.

    5. Subjects with PHQ-8 >10 at Screening or Baseline visits.

    6. Previous treatment with ARQ-151 and ARQ-154.

    7. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks

    8. Known allergies to excipients in ARQ-154 foam

    9. Known or suspected:

    • severe renal insufficiency or moderate to severe hepatic disorders

    • hypersensitivity to component(s) of the investigational products

    • history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current

    1. Subjects with a history of a major surgery within 8 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study

    2. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.

    3. Subjects unable to apply product to the scalp due to physical limitations.

    4. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

    5. A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.

    6. Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.

    7. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects.

    8. Any condition that in the Investigator's assessment would preclude the subject from participating in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arcutis Biotherapeutics Clinical Site 19 Fremont California United States 94538
    2 Arcutis Biotherapeutics Clinical Site 21 Santa Monica California United States 90404
    3 Arcutis Biotherapeutics Clinical Site 42 Coral Gables Florida United States 33134
    4 Arcutis Biotherapeutics Clinical Site 24 Miami Florida United States 33144
    5 Arcutis Biotherapeutics Clinical Site 12 Tampa Florida United States 33613
    6 Arcutis Biotherapeutics Clinical Site 10 Rolling Meadows Illinois United States 60008
    7 Arcutis Biotherapeutics Clinical Site 22 Plainfield Indiana United States 46168
    8 Arcutis Biotherapeutics Clinical Site 15 Louisville Kentucky United States 40217
    9 Arcutis Biotherapeutics Clinical Site 28 Rockville Maryland United States 20850
    10 Arcutis Biotherapeutics Clinical Site 40 Clinton Township Michigan United States 48038
    11 Arcutis Biotherapeutics Clinical Site 20 Detroit Michigan United States 48202
    12 Arcutis Biotherapeutics Clinical Site 14 Fridley Minnesota United States 55432
    13 Arcutis Biotherapeutics Clinical Site 23 High Point North Carolina United States 27262
    14 Arcutis Biotherapeutics Clinical Site 18 Bexley Ohio United States 43209
    15 Arcutis Biotherapeutics Clinical Site 29 Portland Oregon United States 97210
    16 Arcutis Biotherapeutics Clinical Site 27 Pittsburgh Pennsylvania United States 15213
    17 Arcutis Biotherapeutics Clinical Site 13 Arlington Texas United States 76011
    18 Arcutis Biotherapeutics Clinical Site 11 Austin Texas United States 78759
    19 Arcutis Biotherapeutics Clinical Site 41 College Station Texas United States 77845
    20 Arcutis Biotherapeutics Clinical Site 25 Houston Texas United States 77056
    21 Arcutis Biotherapeutics Clinical Site 26 Pflugerville Texas United States 78660
    22 Arcutis Biotherapeutics Clinical Site 17 Norfolk Virginia United States 23502
    23 Arcutis Biotherapeutics Clinical Site 31 Markham Ontario Canada L3P 1X2
    24 Arcutis Biotherapeutics Clinical Site 30 Windsor Ontario Canada N8W 1E6

    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:
    NCT04091646
    Other Study ID Numbers:
    • ARQ-154-203
    First Posted:
    Sep 17, 2019
    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