This study investigates the efficacy of topical roflumilast foam in patients with HS.
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.
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.
Single group
Roflumilast 0.3% topical foam
DrugRoflumilast 0.3% topical foam applied once daily (QD) to all active hidradenitis suppurativa lesions for 16 weeks.
Change from Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
Mean change from baseline in the total abscess and inflammatory nodule (AN) count. AN count is the total number of abscesses and inflammatory nodules assessed at baseline and week 16.
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