Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

Exclusion Criteria

• •1. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
• •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 investigational product to the scalp due to physical limitation.
• •4. Known allergies to excipients in ARQ-154 foam.
• •5. 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 during the study period.
• •6. Known or suspected:
• •* severe renal insufficiency or moderate to severe hepatic disorders
• •* history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent.
• •7. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• •8. Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
• •9. Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
• •10. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
• •11. 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.
• •12. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members that live in the same household of enrolled subjects.
• •Cohort 1 only:
• •13. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
• •14. Subjects that use any Excluded Medication and Treatments.
• •Cohort 2 only:
• •15. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments.
• •16. Subjects with PHQ-8 \>10 or modified PHQ-A \>10 at Screening or Day 1.
• •Cohort 2 subjects that have participated in a prior ARQ-154 study:
• •17. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.