Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tested product group, Control group.
- Who it may be relevant to
- Registry conditions: Aging. Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- 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 - Other Control group
Maintain their normal routine of using cosmetics (cleansers and moisturizers) and normal sun protection habits (if applicable)
Primary outcome measures
- Change in the dermatological assessment of skin signs on the face (Global score) [Time frame: Day0; Day84; Day168; Day252; Day336]
Secondary outcome measures (1)
- Dermatological assessment of skin signs on the face - Atlas Bazin, Flament (Global score) [Time frame: Day0; Day84; Day168; Day252; Day336]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Brazil · 1 center
- CIDP — Rio de Janeiro
Identifiers
NCT: NCT06697288 · LRP23007-2223CBCL064 Anthelios