Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06697288

Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Aging

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIDP

Rio de Janeiro, 20231-048, Brazil

Location status: Recruiting

Location contact

Renato Moura

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Control Group

Other

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

Primary outcomes

  1. Change in the dermatological assessment of skin signs on the face (Global score)

    Time frame: 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 outcomes

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Renato Moura

CONTACT

[email protected]

(55) 21 2221 6180

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

Evaluation of the Efficacy of the UVMune 400 Fluid Sunscreen on the Face Versus Usual Photoprotection Routine on Visible and Measurable Signs of Aging

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.