A 50+ Sunscreen Containing Polypodium Leucotomos Extract, Ellagic Acid, and Niacinamide in Facial Melasma and Photoaging-Related Hyperpigmentation: A Pilot Observational Study Using Line-Field Confocal Optical Coherence Tomography.

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.