Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis

Inclusion criteria

• . Males and females ages 9 years and older (inclusive) at the time of consent.
• . Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at screening as determined by the Investigator. Stable disease for the past 4 weeks.
• . Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
• . An Investigator Global Assessment (IGA) 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.
• . Trial participants in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
• . Women of Childbearing Potential (WOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline (Visit 2). WOCBP must have used highly effective contraception for at least 4 weeks prior to the first study drug administration, and agree to continue using highly effective contraception for 2 months after the last dose. If hormonal contraceptives are used, the dosage must have been stable for a minimum of 4 weeks before the first administration. Alternatively, WOCBP shall use barrier contraception from the time of signing the ICF through 2 months after the last dose. All WOCBP shall have no plan to conceive or donate oocytes throughout the study period.
• . Trial participants are considered reliable and capable of adhering to the protocol and visit schedule according to the Investigator judgment.