Foam could ease painful skin lumps in hidradenitis suppurativa

NCT ID NCT07689188

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

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

12 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

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Contacts and locations

Locations

  • Harrison Dermatology

    Missouri City, Texas, 77459, United States

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