An Open-Label Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa
Harrison Dermatology
Summary
This study investigates the efficacy of topical roflumilast foam in patients with HS.
Description
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.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
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 topi…
Interventions
- DrugRoflumilast 0.3% topical foam
Roflumilast 0.3% topical foam applied once daily (QD) to all active hidradenitis suppurativa lesions for 16 weeks.
Location
- Harrison DermatologyMissouri City, Texas