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

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).