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Also known as Topical roflumilast 0.3% foam, Roflumilast topical 0.3% foam
Roflumilast 0.3% foam · 2 trials · 2 indications
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.
The number of patients achieving a 50% improvement in their facial Vitiligo Area \& Severity Index score (F-VASI 50) at week 24.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3% | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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 |
| Roflumilast topical 0.3% foam | DRUG | Roflumilast 0.3% topical foam |
Inclusion Criteria: * 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...
Roflumilast 0.3% foam is an investigational topical small molecule being studied for non-segmental vitiligo and hidradenitis suppurativa. It is in Phase 2 clinical development for both dermatologic conditions. The foam formulation is applied to the skin and is not yet approved by the FDA.
Roflumilast 0.3% foam is being developed by Arcutis Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARQT. The company is conducting clinical trials to evaluate the safety and efficacy of this topical foam for dermatologic conditions.
Roflumilast 0.3% foam is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The FDA has granted Fast Track designation for this asset, which is intended to expedite the development and review process.
Roflumilast 0.3% foam is being studied in two Phase 2 trials. NCT07077902 evaluates the foam in hidradenitis suppurativa with 10 participants, and NCT07105254 is an open-label proof-of-concept study in pediatric patients with non-segmental vitiligo with 20 participants. Both trials are recruiting in the United States.
Yes, Roflumilast 0.3% foam is also known as topical roflumilast 0.3% foam or Roflumilast topical 0.3% foam. These names refer to the same investigational drug product being developed by Arcutis Biotherapeutics for dermatologic conditions.