Anti-aging Repairing Serum: Efficacy and Tolerability Study

September 28, 2023 updated by: Cosmetique Active International

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil
        • CIDP Brasil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumental Assessment - Primos® Optical 3D
Time Frame: from baseline to Day 84
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)
Time Frame: from baseline to Day 84
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"
Time Frame: from baseline to Day 84
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®
Time Frame: from baseline to Day 84
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cosmetique Active International

Investigators

  • Principal Investigator: Joana Carvalho, Centre International de Développement Pharmaceutique (CIDP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2018

Primary Completion (Actual)

March 14, 2018

Study Completion (Actual)

June 7, 2018

Study Registration Dates

First Submitted

September 23, 2023

First Submitted That Met QC Criteria

September 23, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1718CBCL357-Serum

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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