New foam could ease painful skin condition
NCT ID NCT07077902
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a medicated foam (roflumilast) applied to the skin for hidradenitis suppurativa, a painful inflammatory condition. Ten adults will use the foam alone or with their usual treatments for 4 months. Researchers will check if it improves symptoms and analyze skin gene changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- topical roflumilast 0.3% foam
- What this could lead to
- If it works, this could offer a new topical option to control hidradenitis suppurativa, reducing flares and improving symptoms.
- What could go wrong
- This is a very small early-phase study with only 10 people, so results may not apply broadly. The treatment 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.
- Started
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Sep 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 to 90 years
- 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: * Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent. * Must be 18 years at time of signing informed consent form. * Willing to participate in all required evaluations and procedures in the study including the ability to apply topical medication without difficulty. * Patients must have a diagnosis of HS based upon the clinical criteria of a history of more than or equal 5 typical lesions (erythematous papules, nodules, or abscesses) in flexural sites with a recurring nature over time. * Patients must be candidate for topical therapy defined by active Hurley stage I or Hurley stage II/III with active disease after an adequate trial of systemic antibiotics/hormonal/immunomodulatory or biologic therapy. * Patient is required to be on stable dose of concomitant therapy for at least 3 months before enrollment and throughout the study period. * Females of childbearing potential must have a negative urine pregnancy test at baseline visit and be on adequate contraception throughout the study time. Exclusion Criteria: * Concomitant use of topical antibiotics, topical corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, Hibiclens wash (except for emollients) within 1 week of enrollment. * Increasing or changing dosing for concurrent therapy agents within 90 days before study day 0 and during the study period. * History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease. * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Pregnant or breastfeeding. * Prior major surgery or major life-threatening medical illness within 2 weeks. * Active hepatitis B or C infection with detectible viral nucleic acid in the blood or known Human Immunodeficiency Virus (HIV) positivity. * Patients with known active malignancy. * Any severe systemic illness requiring Intravenous (IV) antibiotics within the two weeks prior to initiation of the study drug. * Active substance abuse or a history of substance abuse within 6 months prior to screening. * Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
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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
4 sites. 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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LCMC Multi-speciality Clinic
RECRUITINGNew Orleans, Louisiana, 70112, United States
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Lakeside Hospital
RECRUITINGNew Orleans, Louisiana, 70001, United States
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Lakeview Hospital
RECRUITINGCovington, Louisiana, 70433, United States
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University Medical Center
RECRUITINGNew Orleans, Louisiana, 70112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Weight-Loss drug also calm a painful skin disease?
- Viruses that kill bacteria: a new weapon against superbugs?
- Can an injected drug calm the painful flares of hidradenitis suppurativa?
- Nanobody drug tested against painful skin condition
- Can a mediterranean diet tame hidradenitis suppurativa?
- Can we predict the path of chronic skin disease?