Anti-aging Repairing Serum: Efficacy and Tolerability Study

NCT06059274 | Completed

• 1 other identifier: 1718CBCL357-Serum
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti-aging

Keywords

anti-aging; skin barrier; dermocosmetic; wrinkles

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Instrumental Assessment - VISIA-6®

  from baseline to Day 84

Study Arms (1)

Topical serum

EXPERIMENTAL

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

Other: Topical serum

Interventions

Topical serum OTHER

Participants are asked to apply the topical serum twice daily for 84 days.

Topical serum

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant, breastfeeding or immune compromised woman
• participant with cutaneous marks or active dermatoses on the tested area that could interfere with the evaluation

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CIDP Brasil

Rio de Janeiro, Brazil

Location

Study Officials

• Joana Carvalho

  Centre International de Développement Pharmaceutique (CIDP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 28, 2023
• Study Start: March 14, 2018
• Primary Completion: March 14, 2018
• Study Completion: June 7, 2018
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

BR (1)