Anti-aging Repairing Serum: Efficacy and Tolerability Study

Cosmetique Active

Status: Completed

Conditions: Anti-aging

Treatments: Other: Topical serum

Study type: Interventional

Funder types: Industry

Identifiers

NCT06059274

1718CBCL357-Serum

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Topical serum

Experimental group

Description:

An investigational topical serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water

Treatment:

Other: Topical serum