PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea

Inclusion Criteria:

• Male or female subjects ≥ 18 years of age at the time of signing the informedconsent document.

• Subject is able to understand and voluntarily sign an informed consent documentprior to participation in any study assessments or procedures.

• Subject is able to adhere to the study visit schedule and other protocolrequirements.

• Diagnosis of SD and baseline IGA ≥ 3 with facial involvement

• OR

• Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12

• Subject agrees to discontinue all treatments for SD and PPR from screening throughstudy completion aside from the study drug

• Subject is judged to be in otherwise good overall health as judged by theinvestigator, based on medical history, physical examination, and laboratorytesting. (NOTE: The definition of good health means a subject does not haveuncontrolled significant co-morbid conditions).

• Females of childbearing potential (FCBP) must have a negative pregnancy test atScreening and Baseline. While on the study drug and for at least 90 days after thelast application of the study drug, male and female participants must be willing totake appropriate contraceptive measures to avoid pregnancy or fathering a child.FCBP who engage in activity in which conception is possible must use one of theapproved contraceptive options described below:

• Option 1: Any one of the following highly effective contraceptive methods:hormonal contraception (oral, injection, implant, transdermal patch, vaginalring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.

• OR

• Option 2: Male or female condom (latex condom or nonlatex condom NOT made outof natural [animal] membrane [for example, polyurethane]); PLUS one additionalbarrier method: (a) diaphragm with spermicide; (b) cervical cap withspermicide; or (c) contraceptive sponge with spermicide.

The female subject's chosen form of contraception must be effective by the time the female subject is enrolled into the study.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

• Subjects with other skin diseases that would interfere with the study assessment inthe opinion of the investigator.

• Active bacterial, fungal, or viral skin infection within 2 weeks from studyinitiation.

• Subject has clinically significant (as determined by the investigator) renal,hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular,neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g.,malignancy, TB, thromboembolic events) that will affect the health of the subjectduring the study, or interfere with the interpretation of study results.

• Subject has previously received treatment with oral or topical PDE4 inhibitors.

• Current other topical treatments (e.g., topical corticosteroids, topical calcineurininhibitors, topical JAK inhibitors, topical metronidazole, topical minocycline,topical ivermectin, topical azelaic acid, topical brimonidine, topicaloxymetazalone, topical antihistamines, topical antibacterials) within 2 weeks ofbaseline.

• Use of systemic non-biologic immunosuppressive medications, including, but notlimited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolatemofetil, azathioprine, methotrexate, tacrolimus, oral JAK inhibitors within 4 weeksof study initiation.

• Use of systemic biologic immunosuppressive medications, including, but not limitedto inhibitors of IL-17, IL-12/23, or IL-23, TNF inhibitors, dupilumab, and abataceptwithin 12 weeks of baseline.

• History of adverse systemic or allergic reactions to any component of the studydrug.

• Current participation in any other study with a biologic investigational medicationwithin 6 months of baseline, or non-biologic investigational medication within 12weeks of baseline.

• Subject who is pregnant or breast feeding.

• SD or PPR Baseline IGA < 3; PPR inflammatory lesion count <12; SD with no facialinvolvement.

• Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIVserology at the time of screening for subjects determined by the investigators to beat high-risk for this disease.