NCT04088006

The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity

A Prospective, Monocentric, Intra-individual, Randomized Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® HydroMax on Skin Moisturization and Elasticity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Laboratoires Vivacy · Industry
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

STYLAGE® HydroMax is a CE-marketed hyaluronic acid gel intended to improve skin moisturization and elasticity through injection into the dermis of the face, neck, neckline area and back of the hand. In this study, 47 female healthy subjects between the ages of 35 and 65, who have signs of cutaneous dryness and lack of elasticity on the cheek and on the neckline area, who have given her informed consent and met all the eligibility criteria, will be enrolled. One month apart subjects will randomly receive 3 injections of product in one cheek and in one side of the neckline area. Subjects will come to a total of 8 visits over a period of 9 months. Variation of moisturization, elasticity and roughness of treated areas in comparison with non-treated areas will be measured using specific devices by independent evaluators. Global aesthetic improvement, subject satisfaction, pain at injection and safety will also be assessed.

Detailed description

This is a prospective, single center, randomized, intra-individual study with blinded evaluators assessing the efficacy and safety of STYLAGE® HydroMax on skin moisturization and elasticity on the cheek and neckline area. Forty seven female subjects will be enrolled and will receive 3 injections of product one month apart on the cheek and neckline area in a randomized fashion with the contralateral non-treated cheek and neckline area. Injection will be performed into the mid to deep dermis of the cheek and neckline area (1 mL per session and per area) by micro-papular injection technique. Subjects will be followed up at 1, 2, 3, 4, 6 and 9 months timepoints. Variation of moisturization, elasticity and roughness of treated areas in comparison with non-treated areas will be measured using Corneometer®, Cutometer®, Dermatop® or Primos Lite® respectively. Global aesthetic improvement, subject satisfaction, pain at injection and safety will also be assessed.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	Injection of STYLAGE® HydroMax	STYLAGE® HydroMax is a hyaluronic acid injectable gel intended to improve skin moisturization and elasticity of the face and neckline area in this study. A total of 3 injection sessions will be performed one month apart for each subject. At each injection session, 1 mL of product will be injected in the mid to deep dermis of one cheek and another 1 mL in one site of neckline area for each subject.

Timeline

• Start date: 2019-09-03
• Primary completion: 2020-01-10
• Completion: 2020-07-08
• First posted: 2019-09-12
• Last updated: 2020-08-04

Locations

1 site across 1 country: France