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

Cosmetique Active

Status: Enrolling

Conditions: Aging

Treatments: Other: Control group; Other: Tested product group

Study type: Interventional

Funder types: Industry

Identifiers

NCT06697288

LRP23007-2223CBCL064 Anthelios

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with signs of photo aging (Global score of at least 14)
• All skin types

Exclusion criteria

• Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site
• Pregnant or breastfeeding women
• Subject with known allergy to cosmetic products or to any ingredient of the sunscreen product

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Tested product group

Experimental group

Description:

Volunteers using the investigational product handed over to them

Treatment:

Other: Tested product group

Control group

Active Comparator group

Description:

Volunteers using their own sun protection routine

Treatment:

Other: Control group