Anti-aging Repairing Serum: Efficacy and Tolerability Study

Study Overview
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Brief Summary
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The study aimed to evaluate the effectiveness and tolerability of a dermocosmetic serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water in reducing skin aging signs. The experimental clinical trial involved 34 participants aged 45 to 65 years who applied the serum twice a day for 84 days.

Detailed Description
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This experimental, mono-centric, open clinical trial was conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice (GCP). Quality control was applied to each stage of data handling to ensure that clinical data were generated, collected, processed, analyzed and reported according to the protocol, Standard Operating Procedures (SOP) and requirement of GCP. Descriptive Statistics: Quantitative parameters, or those that can be reasonably treated as such, were summarized using measures of central tendency as mean and median and dispersion measures as standard deviation at each time of evaluation. Quantitative variables were summarized using frequencies and percentages. For each parameter (clinical evaluation scores and parameters derived from the Primos®) and each region (frontal, periocular, peri-oral and neck), graphical representations of means ± 95% Confidence Interval (CI) were elaborated for visual assessment of evolution over time.

Official Title
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Evaluation of the Efficacy of an Anti-aging Repairing Serum Containing Hyaluronic Acid, Vitamin B5, Madecassoside and La Roche-Posay Thermal Spring Water

Conditions
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Anti-aging

Intervention / Treatment
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* Other: Topical serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: phototype I to IV presenting wrinkles on the forehead and/or peri-orbital area with grade ≥ 2 and ≤4 according to Skin Aging Atlas participant has not used any anti-aging products or performed aesthetic procedures over the last three months Exclusion Criteria: pregnant, breastfeeding or immune compromised woman participant with cutaneous marks or active dermatoses on the tested area that could interfere with the evaluation

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical serum<br>An investigational topical serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water | Other: Topical serum<br>* Participants are asked to apply the topical serum twice daily for 84 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental Assessment - Primos® Optical 3D | The Primos® Optical 3D (Canfield) device in vivo allows the measurement and evaluation of wrinkles through the technique of fringed projection, based on digital mirrors (DMDTM: Digital Mirco mirror Devices) directly on the skin surface of the participants. | from baseline to Day 84 | 
| Clinical assessment through Visual Analog Scale (VAS) | The dermatologist investigates the degree of roughness of the frontal, peri-orbital, peri-oral, neck and overall aspect according to the following parameters: number of wrinkles (no wrinkles / several wrinkles), wrinkles thickness (very thin wrinkle / very thick wrinkle), length of the wrinkle (very short wrinkle / very long wrinkle), depth of wrinkle (very superficial wrinkle / very deep wrinkle) on a line from 0 to 10. | from baseline to Day 84 | 
| Clinical assessment using the standard scale Skin Aging Atlas | The dermatologist investigates the frontal, peri-orbital, peri-oral and neck regions, comparing the roughness observed in the research regions with the images presented in the Skin Aging Atlas, establishing, for each area, a degree of roughness, that made possible the evaluation in the different experimental times. | from baseline to Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental Assessment - VISIA-6® | Standardized photographs with VISIA-6® are taken of the participants' right, left and front profiles using standard and cross-polarized lights. | from baseline to Day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-aging, skin barrier, dermocosmetic, wrinkles