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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorHarrison Dermatology

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Roflumilast 0.3% topical foam

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators