Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
Open-label, long-term safety study of ARQ-154 foam 0.3% in subjects with seborrheic
 dermatitis involving up to 20% total Body Surface Area (BSA). Study medication will be
 applied by the qualifying subjects topically once daily for 52 weeks. Cohort 1 subjects are
 rollover subjects from a prior ARQ-154 trial. Cohort 2 include treatment naive subjects.
 Periodic clinic visits will include assessments for clinical safety, application site
 reactions, and disease improvement or progression.
Inclusion Criteria:

 1. Participants legally competent to sign and give informed consent or (for adolescents)
 assent.

 2. Males and females ages 9 years and older (inclusive) at the time of consent.

 3. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at
 all study visits.

 4. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have
 undergone surgical sterilization.

 Cohort 1 only:

 5. Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154
 study, successfully completed a prior ARQ-154 study through final visit and are able
 to immediately enroll into this long-term safety study on the final visit of the
 previous ARQ-154 study.

 Cohort 2 subjects that have not participated in a prior ARQ-154 study:

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

 7. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous
 areas up to ≤20% BSA involvement.

 8. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3')
 at Day 1.

 9. Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate
 ('2') at Day 1.

 Cohort 2 subjects that have participated in a prior ARQ-154 study:

 10. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as
 determined by the Investigator.

 11. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous
 areas up to ≤20% BSA involvement.

 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.