Hidradenitis SuppurativaPhase 2NCT07077902
A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
A Phase 2 study testing Topical roflumilast 0.3% foam in people with Hidradenitis Suppurativa, run by Tulane University at 4 sites in United States.
Trial summary
This is a phase 2a, open label study. As psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Topical roflumilast 0.3% foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Sep 2025to 28 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lakeview Hospital
Covington, Louisiana, 70433
Lakeside Hospital
New Orleans, Louisiana, 70001
LCMC Multi-speciality Clinic
New Orleans, Louisiana, 70112
University Medical Center
New Orleans, Louisiana, 70112
About this study
Official title: 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 With Correlative Analysis.
This is a phase 2a, open label study.
As psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance and flares in patients with moderate to severe disease. The study will include correlative analysis to study gene expression profiling before and after therapy.
Read the detailed description
With limited topical treatment options available for mild HS and for flare control, the investigators hypothesize that topical roflumilast, a phosphodiesterase-4 inhibitor (PDE4) inhibitor, is a safe and efficacious monotherapy or add-on therapy in HS patients.
The study will investigate the efficacy, safety, and toxicity of topical roflumilast 0.3% foam applied to affected areas once a day as monotherapy in Hurley stage I HS patients and as add-on therapy with daily application for Hurley stage II and III HS patients on 4 months of stable treatment regimen via changes in gene expression compared to pre-treatment using Ribonucleic acid (RNA) derived from tape strip collection.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Topical roflumilast 0.3% foam
- Keywords
- Topical roflumilast, Inflammatory skin condition, Painful nodules and abscesses in axilla and groin
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical roflumilast 0.3% foamDrug
Topical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis
| Study group | Role | What they receive |
|---|---|---|
| HS patients arm | Experimental | 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. Receives: Drug: Topical roflumilast 0.3% foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the change in gene expression profile at week 16 of using topical roflumilast vs baseline
The investigators will perform gene expression profiling (GEP) using RNA sequencing on tape strips collected before and after treatment with topical roflumilast. Sixteen tape strips from lesional skin will be performed before treatment with topical roflumilast and after 4 months of treatment for gene expression profiling.
Measured: Baseline, 16 weeks
Secondary outcomes (3)
Measure the overall response rate of topical roflumilast when applied to the skin of HS patients.
The efficacy assessment will be based on overall response rate (ORR) of topical roflumilast in patients with HS at 4 months.
The ORR will be measured using the change in total abscess and inflammatory nodule count (AN count) at week 16 vs number of active lesions at baseline. Change from baseline will be calculated as the week 16 value minus the baseline value.
Measured: Baseline, 4 months
Measure the change in quality of life for HS patients applying topical roflumilast to their skin
The investigators will assess the patients' quality of life using Dermatology Life Quality Index (DLQI) score ranging from (0-30) where 0 has no effect on quality of life and 30 has an extremely large effect on quality of life. DLQI will be measured at months 0, 1 and 4 months.
The minimal clinically important difference on the DLQI score is a change of 4.
Measured: Baseline, 1 month, 4 months
Measure the change in numerical pain score for HS patients applying topical roflumilast to their skin
The investigators will assess the skin pain response using Numerical Rating Scale (NRS30). NRS an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). NRS will be measured at months 0, 1 and 4 months.
The minimal clinically meaningful important difference on the NRS score is ≥30% reduction and ≥2-point reduction in skin pain from baseline.
Measured: Baseline, 1 month, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Sep 2025
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Arcutis Biotherapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Carole Bitar, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077902
- Sponsor's protocol ID
- 2020-527
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2025
- Last updated
- 9 Oct 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 With Correlative Analysis.
- ClinicalTrials.gov ID
- NCT07077902
- Acronym / sponsor ID
- 2020-527
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Topical roflumilast, Inflammatory skin condition, Painful nodules and abscesses in axilla and groin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Arcutis Biotherapeutics, Inc.
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 22 Jul 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 is a phase 2a, open label study.
As psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance and flares in patients with moderate to severe disease. The study will include correlative analysis to study gene expression profiling before and after therapy.
Detailed description
With limited topical treatment options available for mild HS and for flare control, the investigators hypothesize that topical roflumilast, a phosphodiesterase-4 inhibitor (PDE4) inhibitor, is a safe and efficacious monotherapy or add-on therapy in HS patients.
The study will investigate the efficacy, safety, and toxicity of topical roflumilast 0.3% foam applied to affected areas once a day as monotherapy in Hurley stage I HS patients and as add-on therapy with daily application for Hurley stage II and III HS patients on 4 months of stable treatment regimen via changes in gene expression compared to pre-treatment using Ribonucleic acid (RNA) derived from tape strip collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS patients arm | Experimental | Drug: Topical roflumilast 0.3% foamPatients 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 may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Topical roflumilast 0.3% foamTopical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis | Drug | HS patients arm |
Primary outcome
Measure the change in gene expression profile at week 16 of using topical roflumilast vs baseline
Time frame: Baseline, 16 weeks
The investigators will perform gene expression profiling (GEP) using RNA sequencing on tape strips collected before and after treatment with topical roflumilast. Sixteen tape strips from lesional skin will be performed before treatment with topical roflumilast and after 4 months of treatment for gene expression profiling.
3 secondary outcomes
Measure the overall response rate of topical roflumilast when applied to the skin of HS patients.
Time frame: Baseline, 4 months
Measure the change in quality of life for HS patients applying topical roflumilast to their skin
Time frame: Baseline, 1 month, 4 months
Measure the change in numerical pain score for HS patients applying topical roflumilast to their skin
Time frame: Baseline, 1 month, 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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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. This study is not recruiting at the moment.
Carole Bitar, MD principal investigator
Tulane University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical roflumilast 0.3% foam in people with Hidradenitis Suppurativa, run by Tulane University at 4 sites 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the change in gene expression profile at week 16 of using topical roflumilast vs baseline (time frame: Baseline, 16 weeks). 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 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.