摘要

Objectives: To evaluate whether the Pigmentary Interactome Framework combined with continuous wearable exposome monitoring provides superior clinical improvement, reduced relapse, and safer procedural outcomes compared with standard care in patients with complex, overlapping hyperpigmentation disorders common in skin of colour. Introduction: Complex hyperpigmentation in skin of colour often involves overlapping pathways;epidermal and dermal pigment, subclinical inflammation, vascular change, barrier fragility, and exposome-driven oxidative stress. Conventional linear approaches rarely address this heterogeneity. The Pigmentary Interactome Framework integrates objective interactome profiling with wearable tracking of UV, visible light, pollution, humidity, and behaviour to personalise treatment. This trial evaluates its effectiveness versus standard pigmentary care. Materials / method: In this 12-month randomized trial, 384 adults with complex hyperpigmentation (melasma, PIH, LPP, Riehl’s, and mixed dyschromia) were randomized 1:1 to interactome-guided care or standard therapy. The intervention included TEWL and pigment-depth profiling, vascular mapping, algorithm-directed treatment, wearable UV/light/pollution monitoring, and weekly digital imaging. Primary endpoint: change in GPSI; secondary endpoints: ≥1-grade improvement, relapse, safety, and PROMs. Results: The interactome arm showed greater GPSI reduction (−54.1% vs −26.7%, p<0.001). ≥1-grade improvement was higher (76% vs 39%, p=0.001). Mixed epidermal–dermal pigment depth and vascular indices improved more rapidly. Wearable-captured UV–flare correlation fell by 63%, indicating better photobehaviour. Relapse was lower (12.9% vs 33.6%, p<0.001). Procedural hyperpigmentation risk decreased, with higher adherence and satisfaction. Conclusion: The Pigmentary Interactome Framework with wearable exposome monitoring provides superior, durable improvement in complex hyperpigmentation. By integrating barrier, vascular, inflammatory, and exposomal data into a unified precision pathway, this approach reduces relapse, improves treatment safety, and enhances patient-reported outcomes in skin of colour.