Beth Israel Deaconess Medical Center
This study investigates the efficacy of topical roflumilast foam in patients with HS.
Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition that causes painful and inflamed lumps and abscesses often in the underarms, groin and buttocks. The purpose of this study is to assess the safety and efficacy of QD 0.3% topical roflumilast foam in patients with HS over 16 weeks, with or without previous treatment. The drug involved in this study, 0.3% topical roflumilast foam, is investigational.
Inclusion Criteria: 1. Male or female subjects aged 18 years or older 2. Participants are legally competent to sign and give informed consent. 3. Diagnosis of HS based on clinical history and physical examination for at least 3 months. 4. Diagnosis of HS (Hurley I or II) with a total AN count of at least 4 to ≤ 10, with no draining tunnels at screening and baseline visits with an AN of \>4 affecting at least one distinct anatomical region. 5. Agreement to NOT use topical and systemic antibiotics and intralesional steroids for treatment of HS during the study. 6. Agreement to NOT use a diluted…
Roflumilast foam, 0.3%, is a phosphodiesterase 4 inhibitor
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