NCT06697288

Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging

Evaluation of the Efficacy of the UVMune 400 Fluid Sunscreen on the Face Versus Usual Photoprotection Routine on Visible and Measurable Signs of Aging

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This experimental, randomized study aims at evaluating the preventative effect of a Sun Protection Factor (SPF) 50+ sunscreen (Anthelios UVMUNE 400 Fluid SPF 50+) with high Ultraviolet A (UVA) protection on clinical signs of skin aging.

Detailed description

The study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the International Council on Harmonisation (ICH) Topic E6(R2)5 ref: EMA/CHMP/ICH/135/1995, ICH Good Clinical Practice (GCP) Addendum Nov 2016 and applicable regulatory requirement. Statistical plan: Tx represents the values observed at Time x, for each parameter and by subgroup. Quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables will be summarized in the form of counts and percentages. For each parameter, a graphical representation of the means ±95% Confidence Interval (CI) will be produced to visually assess the evolution across time, by treatment group.

Conditions

• Aging

Interventions

Type	Name	Description
OTHER	Tested product group	Apply the test product per zone at least twice a day on the face, neck (neck \& nape), décolleté and back of the hand in the morning and at midday whatever the weather conditions and the activities of the day
OTHER	Control group	Maintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable)

Timeline

• Start date: 2024-04-03
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-11-20
• Last updated: 2024-11-20

Locations

1 site across 1 country: Brazil