Roflumilast Foam for Vitiligo

This trial tests Roflumilast foam to determine its effectiveness for non-segmental vitiligo, a condition causing patches of skin to lose color. Researchers aim to assess whether this foam can effectively treat these patches, particularly on the face. The trial is open to children and teens who have had the condition for at least three months and have noticeable facial patches. Participants should be generally healthy and able to adhere to the study rules. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial requires participants to stop certain medications before starting, including any biologic or experimental therapy, phototherapy, immunomodulating treatments, and topical treatments. Additionally, you must discontinue systemic CYP3A4 inhibitors or dual inhibitors. Please consult with the study team to see if your current medications are affected.

Research has shown that Roflumilast foam 0.3% is generally safe and well-tolerated. In studies with patients who have seborrheic dermatitis, this foam was used for up to 52 weeks, and few treatment-related side effects occurred. Most side effects were mild to moderate. Additionally, Roflumilast foam has proven effective over time, with results that continue to improve.

Unlike the standard of care for vitiligo, which typically involves topical corticosteroids or calcineurin inhibitors to reduce inflammation and promote repigmentation, Roflumilast Foam is unique because it uses a new delivery method with a novel active ingredient. Roflumilast is a phosphodiesterase-4 (PDE4) inhibitor, which works by targeting and reducing inflammation in the skin more precisely. Researchers are excited about Roflumilast Foam because it could offer a more effective and targeted treatment option with potentially fewer side effects, paving the way for improved skin repigmentation in vitiligo patients.

Studies have shown that roflumilast foam 0.3% effectively and safely treats skin conditions like seborrheic dermatitis, with benefits lasting over a year. Early research suggests that roflumilast cream 0.3% might help children with vitiligo, especially those unresponsive to other treatments. The foam has consistently demonstrated positive effects and is well-tolerated in individuals aged 12 and older. This trial will evaluate the efficacy of roflumilast foam 0.3% specifically for vitiligo, building on early findings that suggest it could be a helpful treatment.¹³⁶⁷⁸