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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
47
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.
Laboratoire DERMSCAN
Villeurbanne, Rhône, France
Variation of cheek cutaneous moisturization
Variation from baseline before treatment (D0) to 3 months after treatment initiation of the cutaneous moisturization on the cheek, in comparison with the non-treated cheek, by an independent evaluator using Corneometer®.
Time frame: Month 3
Variation of cheek cutaneous moisturization
Variation from baseline to 1, 2, 4, 6 and 9 months after treatment initiation of the cutaneous moisturization on the cheek in comparison with the non-treated cheek by a blinded independent evaluator using Corneometer®.
Time frame: Month 1, Month 2, Month 4, Month 6, Month 9
Variation of neckline area cutaneous moisturization
Variation from baseline to 1, 2, 3, 4, 6 and 9 months after treatment initiation of the cutaneous moisturization on the neckline area in comparison with the non-treated neckline area by a blinded independent evaluator using Corneometer®.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of cheek and neckline area cutaneous elasticity
Variation from baseline to 1, 2, 3, 4, 6 and 9 months after treatment initiation of the cutaneous elasticity on the cheek and neckline area in comparison with the non-treated cheek and neckline area by a blinded independent evaluator using Cutometer®.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of cheek cutaneous roughness
Variation from baseline to 1, 2, 3, 4, 6 and 9 months after treatment initiation of the cutaneous roughness on the cheek in comparison with the non-treated cheek by a blinded independent evaluator using Dermatop®.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Variation of neckline area cutaneous roughness
Variation from baseline to 1, 2, 3, 4, 6 and 9 months after treatment initiation of the cutaneous roughness on the neckline area in comparison with the non-treated neckline area by a blinded independent evaluator using Primos Lite®.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of global aesthetic improvement
Evaluation by the subject and by the blinded independent evaluator of the global aesthetic improvement of treated and non-treated zones 1, 2, 3, 4, 6 and 9 months after treatment initiation using the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a 5-score scale (from score 1 to score 5) with minimum scores representing a better outcome. Score 1 corresponds to "Very much improved", score 2 to "Much improved", score 3 to "Improved", score 4 to "No change" and score 5 to "Worse".
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of subject's satisfaction
Evaluation of subject's satisfaction 1, 2, 3, 4, 6 and 9 months after treatment initiation using a questionnaire.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 9
Evaluation of pain during injection
Evaluation of the pain during injection by the subject using a numerical rating scale from 0 to 10.
Time frame: Day 0, Month 1, Month 2
Report of adverse events
Evaluation of product tolerance by collection of adverse events assessed by subject and independent evaluator.
Time frame: Up to Month 9
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