Randomised Controlled Trial of an Antioxidant and Sunscreen Combination Cream for Reducing DNA Damage in Human Skin

Summary

This randomized, double-blind, vehicle-controlled clinical trial investigates whether daily use of an encapsulated SPF 50 formulation containing a multi-antioxidant complex provides greater mitochondrial DNA (mtDNA) protection in human facial skin compared with a vehicle-only cream. Fifty-two healthy adults will be enrolled during the UK spring and randomized 1:1 to receive either the antioxidant-enriched SPF 50 or a matched vehicle (no SPF, no antioxidants). Participants will apply their assigned product once daily to the full face for 12 weeks under ambient ultraviolet (UV) and oxidative exposure. Non-invasive cheek swabs collected at baseline and week 12 will be analyzed by blinded quantitative polymerase chain reaction (qPCR) to assess mtDNA integrity (ΔCt = Ct\_long - Ct\_short). The primary objective is to determine whether the antioxidant-enriched SPF 50 reduces mtDNA damage compared with vehicle. Secondary objectives include comparing the proportion of "responders" showing reduced mtDNA damage (ΔCt \< 0) and evaluating within-participant change among habitual daily sunscreen users. The trial aims to clarify whether adding antioxidants to high-SPF formulations can strengthen daily photoprotection by mitigating residual oxidative stress not fully blocked by UV filters alone.

Timeline

Start

2025-03-01

Primary completion

2025-11-10

Completion

2025-11-10

Drugs

Indications