Status:
COMPLETED
Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
Lead Sponsor:
Arcutis Biotherapeutics, Inc.
Conditions:
Seborrheic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.
Eligibility Criteria
Inclusion
- Participants legally competent to sign and give informed consent.
- Males and females ages 18 years and older (inclusive) at the time of consent.
- Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
- Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas.
- An Investigator Global Assessment (IGA) of 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, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
- Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
Exclusion
- 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.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- 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.
- 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.
- Subjects with PHQ-8 ≥10 at Screening or Baseline visits.
- Previous treatment with ARQ-151 and ARQ-154.
- Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks.
- Known allergies to excipients in ARQ-154 foam.
- Known or suspected: severe renal insufficiency or moderate to severe hepatic disorders; hypersensitivity to component(s) of the investigational products; or history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current.
- 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.
- Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- Subjects unable to apply product to the scalp due to physical limitations.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.
- 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.
- Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects.
- Any condition that in the Investigator's assessment would preclude the subject from participating in the study.
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2020
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT04091646
Start Date
December 4 2019
End Date
August 21 2020
Last Update
July 3 2023
Active Locations (24)
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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