Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa

This study investigates the efficacy of topical roflumilast foam in patients with HS.

Inclusion Criteria: * Male or female subjects aged 12 years or older at time of consent (or assent). * Participants and/or legal guardians are legally competent to sign and give informed consent or assent (for adolescents). * Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 3 months. * Diagnosis of HS (Hurley Stage I or II) with a total abscess and inflammatory nodule (AN) count of at least 4 to ≤10, with no draining tunnels at screening and baseline visits, affecting at least one distinct anatomical region. * Agreement to NOT use topical and systemic antibiotics and intralesional steroids for treatment of HS during the study. * Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study. * Subjects who have had surgery in the treatment area must be at least 3 months post-procedure (applies to deroofing/marsupialization or excision, not incision and drainage). * Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline/Day 1 and agree to use at least one highly effective or barrier method of contraception throughout the study. Females of non-childbearing potential must be premenarchal, postmenopausal (≥12 months spontaneous amenorrhea), or surgically sterile. -In good health as judged by the Investigator based on medical history, targeted physical examination, and vital signs. Subjects and parent(s)/legal guardian(s) must be reliable and capable of adhering to the protocol and visit schedule. Exclusion Criteria: * Medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator. * Inability to discontinue prohibited medications or treatments before Baseline or during the study. * Presence of draining tunnels at Screening or Baseline. * Unwillingness to refrain from prolonged sun exposure or tanning beds/other artificial light-emitting devices for 4 weeks before Baseline and during the study. * Skin conditions other than HS that could interfere with evaluation of study medication. * Conditions in the treatment area that could confound efficacy measurements. * Known allergy to excipients in roflumilast foam. * Use of oral roflumilast (Daxas® or Daliresp®) within 4 weeks before Baseline. * History of severe depression, suicidal ideation, or suicidal behavior at Screening/Baseline. * Pregnant, planning pregnancy during the study, or breastfeeding. * Previous treatment with roflumilast cream or foam or current roflumilast use for another indication expected to continue during the study. * Major surgery within 4 weeks before Baseline or planned during the study. * History of chronic alcohol or drug abuse within 6 months before Screening. * History of cancer within 5 years, except fully treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix. * Parent(s)/legal guardian(s) or subjects unable to communicate, read, or understand the local language, or otherwise unsuitable for participation in the Investigator's opinion. * Family members of the clinical study site, study staff, sponsor, or family members of enrolled subjects living in the same household. * Known or suspected severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C).