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

Last updated: November 18, 2024
Sponsor: Cosmetique Active International
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Treatment

Control group

Tested product group

Clinical Study ID

NCT06697288
LRP23007-2223CBCL064 Anthelios
  • Ages 30-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • All skin types

Exclusion

Exclusion Criteria:

  • Any history of significant dermatological/ophthalmological diseases or conditions ormedical conditions known to alter skin appearance or physiologic response (e.g.diabetes,) which could, in the opinion of the Investigator, preclude topicalapplication of the investigational products and/or interfere with the evaluation ofthe test site

  • Pregnant or breastfeeding women

  • Subject with known allergy to cosmetic products or to any ingredient of thesunscreen product

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: Control group
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • CIDP

    Rio de Janeiro, 20231-048
    Brazil

    Active - Recruiting

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