The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity
Condition: Aging
Study type: Interventional

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.
    

Intervention name(s): Injection of STYLAGE® HydroMax
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Injection of hyaluronic acid gel
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Intra-individual study with treatment of one cheek and one side of neckline area per subject in a randomly fashion.
Variation of moisturization, elasticity and roughness between treated areas and non-treated areas of each subject measured at different study timepoints.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aging; Skin dryness; Skin elasticity; Hyaluronic acid; Injection; Cheek; Neckline area; Healthy subjects; Intra-individual; Independent evaluators; Prospective; Randomized study