Topical Roflumilast Foam for Hidradenitis Suppurativa

Not yet recruiting at 3 trial locations

Overseen By Carole Bitar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tulane University

Must not be taking: Topical antibiotics, Corticosteroids

Disqualifiers: Cardiac, Hepatic, Renal, Malignancy, 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 explores a new foam treatment called roflumilast for individuals with Hidradenitis Suppurativa (HS), a skin condition characterized by painful lumps. Researchers aim to determine if this foam can safely and effectively reduce inflammation in those with mild to severe HS. Individuals with at least five recurring HS lumps in areas such as the armpits or groin, who have not found success with other treatments, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to early efficacy findings.

Will I have to stop taking my current medications?

You need to be on a stable dose of your current medications for at least 3 months before joining the study and continue them throughout the study. However, you cannot use certain topical treatments like antibiotics or corticosteroids within a week of starting the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that roflumilast foam, applied to the skin, is generally safe. In studies involving individuals with seborrheic dermatitis (a skin condition causing scaly patches and redness), participants tolerated the foam well over time, with few treatment-related side effects. Another study found that roflumilast's side effects were minor, and its safety profile was promising. This suggests the treatment might be safe for people with Hidradenitis Suppurativa. However, each condition is different, and individual reactions can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hidradenitis Suppurativa?

Roflumilast foam is unique because it offers a topical treatment option for hidradenitis suppurativa (HS), a condition typically managed with systemic antibiotics, hormonal therapies, or biologics. Unlike traditional systemic treatments, which can have widespread side effects, roflumilast foam is applied directly to the skin, targeting the affected areas with potentially fewer side effects. Researchers are excited about its new mechanism of action, as it works by inhibiting phosphodiesterase-4 (PDE-4), which may reduce inflammation more effectively in HS lesions. This targeted approach could offer relief for patients who have not responded well to other treatments.

What evidence suggests that topical roflumilast foam might be an effective treatment for Hidradenitis Suppurativa?

Research has shown that roflumilast, when used as a foam, might help treat Hidradenitis Suppurativa (HS), a painful skin condition. Some studies suggest that oral roflumilast, which works similarly to the foam, has produced promising results in reducing HS symptoms. Specifically, patients who took oral roflumilast demonstrated improvements in their condition, indicating that the foam could also be effective for HS. While more information exists about the oral form, the foam is expected to offer similar benefits. Early findings indicate that the foam has effectively reduced itchiness in other skin conditions, which could benefit HS patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Carole Bitar, MD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

This clinical trial is for individuals with Hidradenitis Suppurativa (HS), a skin condition. It's open to those with mild cases who need monotherapy and those with moderate to severe cases needing additional treatment for maintenance and flares.

Inclusion Criteria

Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent.

I have Hurley stage I or II/III skin condition and treatments haven't worked.

I am willing and able to follow all study requirements, including applying topical medication.

Exclusion Criteria

Pregnant or breastfeeding.

I have not had major surgery or a severe illness in the last 2 weeks.

Increasing or changing dosing for concurrent therapy agents within 90 days before study day 0 and during the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical roflumilast 0.3% foam applied to affected areas once a day for 4 months

16 weeks

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Roflumilast

Trial Overview The study is testing the safety and effectiveness of a topical foam called Roflumilast 0.3%. It's an open-label phase 2a trial, meaning everyone knows they're getting the medication, which could help control inflammation in HS.

How Is the Trial Designed?

Group I: HS patients arm Experimental Treatment 1 Intervention

Patients must have a diagnosis of HS based upon the clinical criteria of a history of more or equal than 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.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Arcutis Biotherapeutics, Inc.

Industry Sponsor

Trials

22

Recruited

7,600+

Citations

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

NCT07077902 | A Study for Evaluating Safety & Efficacy of ... An Open Label Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam as a Mono or add-on Therapy in the Treatment of Hidradenitis Suppurativa ...

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

Off-label therapeutic potential of topical roflumilast in ... These findings suggest that there may be some benefit with the systemic use of roflumilast for the treatment of HS. However, HS often affects ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9805069/

Considerable improvement in hidradenitis suppurativa with ... In addition, the patient achieved a 10% weight loss, which may have contributed to the reduction of disease burden. Roflumilast could represent ...

5. arcutis.com arcutis.com/arcutis-announces-publication-of-positive-long-term-safety-and-efficacy-data-of-zoryve-roflumilast-foam-0-3-in-individuals-with-seborrheic-dermatitis-in-american-journal-of-clinical-dermatolog/

News & Media Treatment with ZORYVE foam resulted in sustained improvement in itch, as measured by the Worst Itch Numeric Rating Scale (WI-NRS), with 71.3% ( ...

6. dermatologytimes.com dermatologytimes.com/view/roflumilast-foam-shows-long-term-safety-in-seborrheic-dermatitis

Roflumilast Foam Shows Long-Term Safety in Seborrheic ... Clinical Takeaways​​ Long-term safety: Roflumilast foam 0.3% was well-tolerated over 52 weeks, with low rates of treatment-related adverse events.