# 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

## TL;DR

A sunscreen with specific ingredients may help reduce facial hyperpigmentation and melasma with good tolerability.

## Contribution

A novel sunscreen formulation with ellagic acid, niacinamide, and PLE was tested for melasma and hyperpigmentation.

## Key findings

- MASI scores decreased by 44% after 12 weeks of sunscreen use.
- LC-OCT showed reduced pigment scores and fewer hyper-reflective cells.
- The product was well tolerated with minimal side effects.

## Abstract

Melasma is an acquired facial hyperpigmentation disorder that disproportionately affects sun‐exposed areas. Current treatments show limited efficacy and tolerability.

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).

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.

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.

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.

clinical registration number ISRCTN18053239