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| Name | Class |
|---|---|
| Arcutis Biotherapeutics, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical roflumilast 0.3% foam | Drug | Topical roflumilast is a potent phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of psoriasis, seborrheic dermatitis and atopic dermatitis |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carole Bitar, MD | Contact | 504-988-5114 | cbitar@tulane.edu | |
| Edward Coleman, MS | Contact | 504-988-5135 | ecoleman@tulane.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carole Bitar, MD | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeview Hospital | Recruiting | Covington | Louisiana | 70433 | United States |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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| 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. | 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. | Baseline, 1 month, 4 months |
| Lakeside Hospital | Recruiting | New Orleans | Louisiana | 70001 | United States |
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| LCMC Multi-speciality Clinic | Recruiting | New Orleans | Louisiana | 70112 | United States |
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| University Medical Center | Recruiting | New Orleans | Louisiana | 70112 | United States |
|
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |