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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Other: Tested product group; Other: Control group

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 Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renato Moura; Phone Number: (55) 21 2221 6180; Email: renato.moura.b@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20231-048
    • Recruiting
    • CIDP
    • Contact: Renato Moura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tested product group; Volunteers using the investigational product handed over to them	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
Active Comparator: Control group; Volunteers using their own sun protection routine	Other: Control group; Maintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the dermatological assessment of skin signs on the face (Global score)	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)].	Day0; Day84; Day168; Day252; Day336

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score)	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	Day0; Day84; Day168; Day252; Day336

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Principal Investigator: Renato Moura, Centre International de Développement Pharmaceutique

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: preventive effect; skin aging; Anthelios UVMUNE 400 Oil Control Fluid SPF 50+
• Other Study ID Numbers: LRP23007-2223CBCL064 Anthelios

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No