The Safety and Efficacy of Roflumilast Foam in HS

Exclusion Criteria

• •1. 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
• •2. 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).
• •3. Presence of draining tunnels at screening or at baseline visits
• •4. 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.
• •5. Subjects with skin conditions other than HS that would interfere with evaluations of the effect of the study medication on HS, as determined by the Investigator.
• •6. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• •7. Known allergies to excipients in Roflumilast foam (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate).
• •8. Subjects who cannot discontinue the use of systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously for 2 weeks prior to Baseline/Day 1 and during the study period.
• •9. Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/ Day 1.
• •10. History of severe depression, suicidal ideation or behavior at Baseline/Screening
• •11. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• •12. Previous treatment with Roflumilast cream or foam (any potency) or current Roflumilast use for any other indication at the baseline visit that would be expected to continue during the trial.
• •13. Subjects with a history of major surgery within 4 weeks prior to Baseline/Day 1 or subjects who have major surgery planned during the study.
• •14. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
• •15. Current or a history of cancer within 5 years except for fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
• •16. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
• •17. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.