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

A vizsgálat adatai

Ki végzi

Harrison Dermatology

Azonosító

NCT07689188

A regiszteradat frissítve

2026. október 13.

Eredeti leírás

This study investigates the efficacy of topical roflumilast foam in patients with HS.A teljes eredeti leírásKevesebb

An Open-Label Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa

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

Bevonási feltételek: 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 topical and systemic antibiotics and intralesional steroids for treatment of HS during the study; Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study; Subjects who have had surgery in the treatment area must be at least 3 months post-procedure (applies to deroofing/marsupialization or excision, not incision and drainage); Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline/Day 1 and agree to use at least one highly effective or barrier method of contraception throughout the study; Females of non-childbearing potential must be premenarchal, postmenopausal (≥12 months spontaneous amenorrhea), or surgically sterile; -In good health as judged by the Investigator based on medical history, targeted physical examination, and vital signs. Subjects and parent(s)/legal guardian(s) must be reliable and capable of adhering to the protocol and visit schedule.

Kizáró feltételek: Inability to discontinue prohibited medications or treatments before Baseline or during the study; Unwillingness to refrain from prolonged sun exposure or tanning beds/other artificial light-emitting devices for 4 weeks before Baseline and during the study; Use of oral roflumilast (Daxas® or Daliresp®) within 4 weeks before Baseline; Previous treatment with roflumilast cream or foam or current roflumilast use for another indication expected to continue during the study; Major surgery within 4 weeks before Baseline or planned during the study; History of chronic alcohol or drug abuse within 6 months before Screening; Medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator; Skin conditions other than HS that could interfere with evaluation of study medication; Conditions in the treatment area that could confound efficacy measurements; Known allergy to excipients in roflumilast foam; History of severe depression, suicidal ideation, or suicidal behavior at Screening/Baseline; History of cancer within 5 years, except fully treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix; Known or suspected severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C); Presence of draining tunnels at Screening or Baseline; Pregnant, planning pregnancy during the study, or breastfeeding; Parent(s)/legal guardian(s) or subjects unable to communicate, read, or understand the local language, or otherwise unsuitable for participation in the Investigator's opinion; Family members of the clinical study site, study staff, sponsor, or family members of enrolled subjects living in the same household.

ClinicalTrials.gov NCT07689188