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

Not Applicable

Recruiting

• Conditions: Aging

• Registration Number: NCT06697288
• Lead Sponsor: Cosmetique Active International

Brief 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.

Study Timeline

• Study Start: 2024-04-03
• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the dermatological assessment of skin signs on the face (Global score)	Day0; Day84; Day168; Day252; Day336	Assessment of the skin parameters: Skin roughness \[absent (0), mild (2), moderate (4), severe (6)\]; Skin laxity \[absent (0), mild (2), moderate (4), severe (6)\]; Skin suppleness \[high(0), moderate (2),low (4), absent (6)\]; Skin radiance \[highly radiant (0), radiant (2), normal(4), dull(6), highly dull(8)\]; Pigmented spots \[absent (0), visible (2), highly visible (4)\]; Skin tone homogeneity \[homogeneous (0), non-homogeneous (2)\].

Secondary Outcome Measures

Name	Time	Method
Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score)	Day0; Day84; Day168; Day252; Day336	Assessment of the skin parameters: Forehead wrinkles (0 - 5); Crow feet wrinkles number (1 - 4); Crow feet wrinkles deepness (1 - 6); Glabellar wrinkles (0 - 5); Glabellar fine lines (0 - 5); Underneath eye wrinkle (0 - 5); Corner mouth wrinkle (0 - 6); Nasolabial fold (0 - 5); Upper lip wrinkles (0 - 6); Neck fold (0 - 5); Neck sagging (0 - 5); Ptosis (0 - 5); Eye bags (0 - 5

Trial Locations

Locations (1)

CIDP; 🇧🇷 Rio de Janeiro, Brazil