A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa

Inclusion Criteria:

• Must understand the risks and the benefits/purpose of the study and provide signedand dated informed consent.

• Must be 18 years at time of signing informed consent form.

• Willing to participate in all required evaluations and procedures in the studyincluding the ability to apply topical medication without difficulty.

• Patients must have a diagnosis of HS based upon the clinical criteria of a historyof more than or equal 5 typical lesions (erythematous papules, nodules, orabscesses) in flexural sites with a recurring nature over time.

• Patients must be candidate for topical therapy defined by active Hurley stage I orHurley stage II/III with active disease after an adequate trial of systemicantibiotics/hormonal/immunomodulatory or biologic therapy.

• Patient is required to be on stable dose of concomitant therapy for at least 3months before enrollment and throughout the study period.

• Females of childbearing potential must have a negative urine pregnancy test atbaseline visit and be on adequate contraception throughout the study time.

Exclusion Criteria:

• Concomitant use of topical antibiotics, topical corticosteroids, resorcinol, benzoylperoxide, vitamin D analogs, Hibiclens wash (except for emollients) within 1 week ofenrollment.

• Increasing or changing dosing for concurrent therapy agents within 90 days beforestudy day 0 and during the study period.

• History of any clinically significant (as determined by the investigator) cardiac,endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic, or other major uncontrolled disease.

• Any condition, including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study or confoundsthe ability to interpret data from the study.

• Pregnant or breastfeeding.

• Prior major surgery or major life-threatening medical illness within 2 weeks.

• Active hepatitis B or C infection with detectible viral nucleic acid in the blood orknown Human Immunodeficiency Virus (HIV) positivity.

• Patients with known active malignancy.

• Any severe systemic illness requiring Intravenous (IV) antibiotics within the twoweeks prior to initiation of the study drug.

• Active substance abuse or a history of substance abuse within 6 months prior toscreening.

• Use of any investigational drug within 4 weeks prior to randomization, or 5pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).