Clinical trial NCT06059274: Anti-aging Repairing Serum: Efficacy and Tolerability Study
Official title: Evaluation of the Efficacy of an Anti-aging Repairing Serum Containing Hyaluronic Acid, Vitamin B5, Madecassoside and La Roche-Posay Thermal Spring Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-aging
Keywords: anti-aging
skin barrier
dermocosmetic
wrinkles
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 34
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Instrumental Assessment - Primos® Optical 3D
timeFrame: from baseline to Day 84
measure: Clinical assessment through Visual Analog Scale (VAS)
timeFrame: from baseline to Day 84
measure: Clinical assessment using the standard scale "Skin Aging Atlas"
timeFrame: from baseline to Day 84
Secondary outcomes:
measure: Instrumental Assessment - VISIA-6®
timeFrame: from baseline to Day 84
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: CIDP Brasil
Study officials:
affiliation: Centre International de Développement Pharmaceutique (CIDP)
name: Joana Carvalho
role: PRINCIPAL_INVESTIGATOR
References: