Roflumilast 0.3% Foam for Hidradenitis Suppurativa in Teens and Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, interventional trial evaluates the safety and efficacy of once-daily 0.3% roflumilast topical foam in people with hidradenitis suppurativa (HS). Eligible participants are adolescents aged 12 and older and adults with Hurley stage I or II HS and a defined number of abscesses and inflammatory nodules. Participants will refrain from other HS-directed topical or systemic antibiotics and antiseptics during the study to isolate the foam's effects. The study duration is 16 weeks, and the investigational foam may be used with or without prior HS treatments. Primary outcomes focus on reduction of HS lesions and overall disease activity, with safety monitoring throughout.

Why it matters

Who can join: the full rules

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 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.

Exclusion Criteria:

* 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.
* 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.
* Use of oral roflumilast (Daxas® or Daliresp®) within 4 weeks before Baseline.
* History of severe depression, suicidal ideation, or suicidal behavior at Screening/Baseline.
* Pregnant, planning pregnancy during the study, or breastfeeding.
* 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.
* History of cancer within 5 years, except fully treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix.
* 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.
* Known or suspected severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C).

Where it's running

• Harrison Institute for Clinical Research at Harrison Dermatology
  Missouri City, Texas, United States Recruiting

Study contacts

• Principal investigator: Harrison P Nguyen, MD, MBA, MPH, FAAD, DTM&H — Harrison Dermatology | Harrison Institute for Clinical Research
• Study coordinator: Harrison P Nguyen, MD, MBA, MPH, FAAD, DTM&H
• Email: harrison.nguyen@harrisonderm.com
• Phone: 346.771.3990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Brain activity patterns in people with hidradenitis suppurativa and how treatments may relate to changes

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• Global health study on hidradenitis suppurativa

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• Secukinumab in Chinese adults with moderate to severe hidradenitis suppurativa

  This trial tests two dosing regimens of secukinumab to see if they can help Chinese adults with moderate to severe hidradenitis suppurativa.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.