Jeune Announces Positive Results and Significant Aesthetic Improvements from Phase 1 Study of KB304 for Moderate to Severe Wrinkles of the Décolleté

Core Insights - Jeune Aesthetics, Inc. announced positive safety and efficacy results for KB304, a treatment aimed at restoring skin by delivering collagen and elastin, with significant improvements in skin attributes such as wrinkles and elasticity [1][7][9] Study Results - The PEARL-2 study was a randomized, double-blind, placebo-controlled Phase 1 trial involving 19 subjects, with 12 receiving KB304 and 7 receiving placebo [4][13] - At three months post-treatment, 100% of KB304 subjects reported at least a one-point improvement in wrinkles, compared to 28.6% in the placebo group [5] - Subject Satisfaction Questionnaire (SSQ) indicated that 81.8% of KB304 subjects reported improved satisfaction with their wrinkles' appearance, versus 14.3% for placebo [5] Additional Findings - Improvements were also noted in other skin attributes such as elasticity, crepiness, hydration, and radiance, with 100% of KB304 subjects showing at least a one-point improvement across these metrics at all assessment points [6] - The safety profile of KB304 was consistent with previous studies, with mild-to-moderate adverse events reported, primarily after the first dose, and no severe drug-related adverse events [8] Future Development - Based on the positive results, KB304 will progress to Phase 2 development for treating wrinkles in the décolleté, a site with no FDA-approved injectable products [9] - Jeune plans to meet with the FDA to discuss the Phase 2 study protocol, aiming to initiate the study in the first half of 2026 [9]