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

NCT06697288 | Recruiting

• 1 other identifier: LRP23007-2223CBCL064 Anthelios
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

skin aging; Anthelios UVMUNE 400 Oil Control Fluid SPF 50+; preventive effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score)

  Day0; Day84; Day168; Day252; Day336

Study Arms (2)

Tested product group

EXPERIMENTAL

Volunteers using the investigational product handed over to them

Other: Tested product group

Control group

ACTIVE COMPARATOR

Volunteers using their own sun protection routine

Other: Control group

Interventions

Tested product group OTHER

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

Tested product group

Control group OTHER

Maintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable)

Control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CIDP

Rio de Janeiro, 20231-048, Brazil

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Renato Moura

  Centre International de Développement Pharmaceutique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato Moura

CONTACT

(55) 21 2221 6180; renato.moura.b@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: April 3, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

BR (1)