Phase 2 Study to Evaluate Safety and Effectiveness of Topical Zabalafin Hydrogel Compared to Placebo in Treating Mild to Moderate Atopic Dermatitis

What this Trial Is About

Researchers are evaluating the effectiveness of zabalafin hydrogel in people aged 2 years and older who have mild to moderate atopic dermatitis, also known as eczema. This Phase 2b randomized, double-blind study includes two groups one with mild to moderate atopic dermatitis and another with the same condition plus a secondary skin infection. The study aims to compare zabalafin hydrogel to a placebo vehicle to understand its impact on eczema symptoms using a validated global assessment scale. Participants will be randomly assigned in a 21 ratio to receive either zabalafin 9.5% hydrogel or a placebo gel. The study treatment lasts 16 weeks following up to 2 weeks of screening. During treatment, participants will visit the clinic every 2 weeks for the first month and then monthly until the end of the study. The study evaluates not only the effectiveness but also the safety and tolerability of zabalafin compared to the placebo. Throughout the study, participants will undergo assessments including the validated Investigators Global Assessment, Eczema Area and Severity Index, pruritus itching rating, and patient-reported eczema measures. Safety monitoring and evaluation of antibacterial effects in those with skin infections are included. Participants must comply with study procedures, avoid using other topical products on the eczema lesions, and attend scheduled visits over the approximately 16-week treatment period.

Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.