Roflumilast Foam for Hidradenitis Suppurativa

Overseen By Martina Porter, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: CYP3A4 inhibitors

Disqualifiers: Draining tunnels, Severe depression, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new foam treatment, roflumilast, to determine its effectiveness for hidradenitis suppurativa, a skin condition causing painful lumps. The goal is to assess whether daily application of this foam can effectively reduce symptoms. Participants must have been diagnosed with hidradenitis suppurativa for at least three months and experience painful lumps without draining tunnels. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications, including topical and systemic antibiotics, intralesional steroids, and systemic CYP3A4 inhibitors, for a specified period before and during the study. If you are taking any of these, you will need to stop them to participate.

Is there any evidence suggesting that roflumilast foam is likely to be safe for humans?

Research shows that roflumilast foam is generally easy to use without problems. In studies where participants applied roflumilast foam once a day, it proved safe, causing few side effects. Earlier research found that users experienced very few negative reactions while benefiting from its anti-inflammatory effects. This suggests the treatment is safe for use on the skin. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Roflumilast Foam is unique because it offers a new approach to treating Hidradenitis Suppurativa by using a topical foam formulation, which is different from the more common oral antibiotics and biologics currently used. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which can help reduce inflammation directly on the skin where the painful nodules and abscesses occur. Researchers are excited because this targeted method could lead to fewer systemic side effects and be more convenient for patients to apply directly to affected areas.

What evidence suggests that roflumilast foam might be an effective treatment for hidradenitis suppurativa?

Research suggests that roflumilast foam might help treat hidradenitis suppurativa (HS). One study showed that applying 0.3% roflumilast foam daily for 16 weeks benefited patients with HS. This trial will specifically test the effectiveness of roflumilast 0.3% topical foam applied daily to all active areas over a 16-week period. Evidence also indicates that oral roflumilast can help with HS, suggesting the foam might work similarly. The foam likely reduces swelling, a major issue in HS. Early results are promising, but more research is needed to confirm its effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

Martina Porter, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This clinical trial is for individuals with Hidradenitis Suppurativa (HS), a skin condition that causes small, painful lumps under the skin. The eligibility criteria are not fully listed, but typically include having a certain severity of HS and being within a specific age range.

Inclusion Criteria

I have been diagnosed with HS for at least 3 months.

I am not pregnant and will use effective birth control during the trial.

I am a woman who cannot have children because I am post-menopausal or have been surgically sterilized.

Exclusion Criteria

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 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 0.3% topical roflumilast foam applied once daily for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Roflumilast Foam

Trial Overview The trial is testing Roflumilast 0.3% topical foam to see if it's safe and effective in treating HS. Participants will apply the foam to affected areas as directed to assess improvement in their symptoms over time.

How Is the Trial Designed?

Group I: Roflumilast 0.3% topical foam Experimental Treatment 1 Intervention

Roflumilast 0.3% topical foam to be applied QD to all active fields for the duration of the 16-week trial.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07077902

NCT07077902 | A Study for Evaluating Safety & Efficacy of ... A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa. ClinicalTrials.gov ID NCT07077902.

2. jaadreviews.org jaadreviews.org/article/S2950-1989(25)00074-1/fulltext

Off-label therapeutic potential of topical roflumilast in ... These findings suggest that topical roflumilast may be an effective alternative for the treatment of CNSSF, though larger studies are needed to ...

3. jaad.org jaad.org/article/S0190-9622(24)01806-1/fulltext

52267 Effectiveness and safety of oral roflumilast in ... Oral roflumilast shows promising effect with an acceptable safety profile and may possess a therapeutic potential in otherwise refractory patients with HS.

4. ajmc.com ajmc.com/view/late-breaking-abstracts-highlight-promising-therapies-in-atopic-dermatitis-hidradenitis-suppurativa

Late-Breaking Abstracts Highlight Promising Therapies in ... Roflumilast was also found to be effective at a 0.15% dose in a phase 3 trial of patients aged 6 years and older. This study aimed to determine ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07263230

The Safety and Efficacy of Roflumilast Foam in HS 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 ...

6. arcutis.com arcutis.com/pipeline/topical-roflumilast-foam/

Topical Roflumilast Foam - ARQ-154 We are advancing proof-of-concept Phase 2 studies to explore the potential of ZORYVE (roflumilast) foam 0.3% for the treatment of hidradenitis suppurativa (HS) ...