ABSTRACT Introduction Melasma is an acquired facial hyperpigmentation disorder that disproportionately affects sun‐exposed areas. Current treatments show limited efficacy and tolerability. Aim To assess, in a non‐controlled prospective pilot trial, the efficacy of a fluid cream SPF 50+ sunscreen containing ellagic acid, niacinamide, and a non‐UV‐filtering extract of Polypodium leucotomos (PLE). Methods Twenty women (mean age 40 ± 10 years) with melasma or sun‐induced hyperpigmentation applied the sunscreen every morning and every 2 h during sun exposure for 12 weeks. The primary endpoint was the change in Melasma Area and Severity Index (MASI) at week 12 and week 24 (follow‐up). The secondary endpoints were Line‐field Confocal Optical Coherence Tomography (LC‐OCT) evaluation of pigment distribution and hyper‐reflective cells. Local tolerability was also assessed. Results All subjects completed the study. Baseline MASI (6.9 ± 3.2) decreased to 4.4 ± 3.3 at week 12 and 3.9 ± 3.1 at week 24 (−44% from baseline, p = 0.0001). LC‐OCT pigment scores declined from 2.2 ± 0.8 to 1.5 ± 0.6 at week 24 ( p = 0.04), and hyper‐reflective cells decreased from 47% to 26%. The product was well tolerated, with tolerability scores near to zero. Conclusion This pilot proof‐of‐concept study suggests that an SPF 50+ sunscreen containing ellagic acid, niacinamide, and PLE may reduce melasma severity and improve hyperpigmentation with excellent tolerability. These findings warrant confirmation in larger controlled trials. Trial Registration clinical registration number ISRCTN18053239
Villani et al. (Sun,) studied this question.