The Safety and Efficacy of Roflumilast Foam in HS
ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
This study investigates the efficacy of topical roflumilast foam in patients with HS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects aged 18 years or older
Participants are legally competent to sign and give informed consent.
Diagnosis of HS based on clinical history and physical examination for at least 3 months.
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.
Disqualifiers
Subjects with any medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (see table of Excluded Medications and Treatments with washout timelines).
Presence of draining tunnels at screening or at baseline visits
Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
Trial design
Design model
Single group
Treatments tested in this trial
Roflumilast 0.3% topical foam
DrugRoflumilast foam, 0.3%, is a phosphodiesterase 4 inhibitor
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Roflumilast 0.3% topical foamExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change from Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16.
Change from Baseline was calculated as the Week 16 value minus the Baseline value. Baseline counts were defined as abscesses and/or inflammatory nodules present at Baseline, any new nodules identified after baseline were not counted.
Time frame
Baseline and Week 16Sponsors and contacts
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Source ClinicalTrials.gov