Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
Condition: Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Intervention: Roflumilast Foam 0.3%; Vehicle foam
Intervention description: Roflumilast foam for topical application.; Vehicle foam for topical application.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 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; or
             history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS
             indicative of suicidal ideation, whether lifetime or recent/current.

         10. 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.

         11. Subjects with any condition on the treatment area which, in the opinion of the
             Investigator, could confound efficacy measurements.

         12. Subjects unable to apply product to the scalp due to physical limitations.

         13. Females who are pregnant, wishing to become pregnant during the study, or are
             breast-feeding.

         14. A clinically relevant history of abuse of alcohol or other drugs, at the discretion of
             the Investigator.

         15. 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.

         16. Subjects who are family members of the clinical study site, clinical study staff, or
             sponsor, or family members of enrolled subjects.

         17. Any condition that in the Investigator's assessment would preclude the subject from
             participating in the study.