Foam could ease painful skin lumps in hidradenitis suppurativa
NCT ID NCT07689188
First seen Jul 08, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tests a medicated foam called roflumilast applied daily to hidradenitis suppurativa (HS) lesions for 16 weeks. It includes adolescents and adults with mild to moderate HS (Hurley stage I or II) who have 4 to 10 painful lumps or abscesses but no draining tunnels. The main goal is to see if the foam reduces the number of abscesses and inflamed nodules. This is an early, small trial to check safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Roflumilast 0.3% topical foam
- What this could lead to
- If effective, this foam could offer a new topical treatment option for hidradenitis suppurativa, reducing painful lumps and abscesses.
- What could go wrong
- This is a small early-phase trial with only 10 participants, so results may not apply widely. The foam may not work or could cause skin irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Harrison Dermatology
Missouri City, Texas, 77459, United States
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