Anti-aging Repairing Serum: Efficacy and Tolerability Study

Sponsor

Cosmetique Active International (Industry)

Overall Status

Completed

CT.gov ID

NCT06059274

Collaborator

(none)

Enrollment

Location

Arm

2.8

Actual Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anti-aging	Other: Topical serum	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 14, 2018

Actual Primary Completion Date :

Mar 14, 2018

Actual Study Completion Date :

Jun 7, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Instrumental Assessment - Primos® Optical 3D [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.
Clinical assessment through Visual Analog Scale (VAS) [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.
Clinical assessment using the standard scale "Skin Aging Atlas" [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.

Secondary Outcome Measures

Instrumental Assessment - VISIA-6® [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CIDP Brasil	Rio De Janeiro		Brazil

Sponsors and Collaborators

Cosmetique Active International

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cosmetique Active International

ClinicalTrials.gov Identifier:

NCT06059274

Other Study ID Numbers:

1718CBCL357-Serum

First Posted:

Sep 28, 2023

Last Update Posted:

Oct 2, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cosmetique Active International

Study Results

No Results Posted as of Oct 2, 2023