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.
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
- Are there results?
- Not yet: the study is under way
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.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Martina Porter, MD, 6176675834, clears@bidmc.harvard.edu
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.
- Conditions
- Hidradenitis Suppurativa (HS)
- 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 group | Role | What they receive |
|---|---|---|
| Roflumilast 0.3% topical foam | Experimental | Roflumilast 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.
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.
- First posted4 Dec 2025
- Study start1 Sep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Porter, Beth Israel Deaconess Medical Center
- Investigators
- Martina Porter, MD, Principal investigator, Beth Israel Deaconess Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07263230
- Acronym / sponsor ID
- 2025P000987
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- HS, Hidradenitis Suppurativa, Roflumilast, Topical medication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the efficacy of topical roflumilast foam in patients with HS.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roflumilast 0.3% topical foam | Experimental | Drug: Roflumilast 0.3% topical foamRoflumilast 0.3% topical foam to be applied QD to all active fields for the duration of the 16-week trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast 0.3% topical foamAlso: ZORYVERoflumilast foam, 0.3%, is a phosphodiesterase 4 inhibitor | Drug | Roflumilast 0.3% topical foam |
Primary outcome
Mean Change from Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16.
Time frame: Baseline and 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa (HS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martina Porter, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Porter, MD (6176675834, clears@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16. (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.