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

NCT ID: NCT06697288

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Tested product group

Volunteers using the investigational product handed over to them

Group Type EXPERIMENTAL

Tested product group

Intervention Type 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

Volunteers using their own sun protection routine

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Control group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cosmetique Active International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renato Moura

Role: PRINCIPAL_INVESTIGATOR

Centre International de Développement Pharmaceutique

Locations

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CIDP

Rio de Janeiro, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Renato Moura

Role: CONTACT

(55) 21 2221 6180

Facility Contacts

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Renato Moura

Role: primary

Other Identifiers

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LRP23007-2223CBCL064 Anthelios

Identifier Type: -

Identifier Source: org_study_id

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