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Hidradenitis Suppurativa (HS)Phase 2NCT07263230

The Safety and Efficacy of Roflumilast Foam in HS

A Phase 2 study testing Roflumilast 0.3% topical foam in people with Hidradenitis Suppurativa (HS), run by Beth Israel Deaconess Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This study investigates the efficacy of topical roflumilast foam in patients with HS. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa (HS)
What is being tested?
Roflumilast 0.3% topical foam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to May 2029
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged 18 years or older
  • Participants are legally competent to sign and give informed consent.
  • Diagnosis of HS based on clinical history and physical examination for at least 3 months.
  • Diagnosis of HS (Hurley I or II) with a total AN count of at least 4 to ≤ 10, with no draining tunnels at screening and baseline visits with an AN of >4 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 beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
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  • Subjects who have had surgery in the treatment area should be at least 3 months post procedure (this applies to deroofing/ marsupialization or excision, not incision \& drainage)
  • Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening and Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. The use of abstinence as a contraceptive measure is acceptable if this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.
  • Females of non-childbearing potential should be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).
  • 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) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Who cannot join

  • Subjects with any medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
  • Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (see table of Excluded Medications and Treatments with washout timelines).
  • Presence of draining tunnels at screening or at baseline visits
  • Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
  • Subjects with skin conditions other than HS that would interfere with evaluations of the effect of the study medication on HS, as determined by the Investigator.
  • Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
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  • Known allergies to excipients in Roflumilast foam (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate).
  • Subjects who cannot discontinue the use of systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously for 2 weeks prior to Baseline/Day 1 and during the study period.
  • Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/ Day 1.
  • History of severe depression, suicidal ideation or behavior at Baseline/Screening
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  • Previous treatment with Roflumilast cream or foam (any potency) or current Roflumilast use for any other indication at the baseline visit that would be expected to continue during the trial.
  • Subjects with a history of major surgery within 4 weeks prior to Baseline/Day 1 or subjects who have major surgery planned during the study.
  • Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
  • Current or a history of cancer within 5 years except for fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
  • Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
  • Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Martina Porter, MD contact

6176675834

clears@bidmc.harvard.edu

United States1 site, 1 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Martina Porter, MD, 6176675834, clears@bidmc.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: An Open-label Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Hidradenitis Suppurativa

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

Read the detailed description

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition that causes painful and inflamed lumps and abscesses often in the underarms, groin and buttocks. The purpose of this study is to assess the safety and efficacy of QD 0.3% topical roflumilast foam in patients with HS over 16 weeks, with or without previous treatment. The drug involved in this study, 0.3% topical roflumilast foam, is investigational.

Being tested
Roflumilast 0.3% topical foam
Keywords
HS, Hidradenitis Suppurativa, Roflumilast, Topical medication
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roflumilast 0.3% topical foamDrug

    Also called ZORYVE

    Roflumilast foam, 0.3%, is a phosphodiesterase 4 inhibitor

Study groups in NCT07263230
Study groupRoleWhat they receive
Roflumilast 0.3% topical foamExperimentalRoflumilast 0.3% topical foam to be applied QD to all active fields for the duration of the 16-week trial.
Receives: Drug: Roflumilast 0.3% topical foam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change from Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16.

    Change from Baseline was calculated as the Week 16 value minus the Baseline value. Baseline counts were defined as abscesses and/or inflammatory nodules present at Baseline, any new nodules identified after baseline were not counted.

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2025
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07263230
Sponsor's protocol ID
2025P000987
Status last verified
Jul 2026
First submitted
24 Nov 2025
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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