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

NCT04088006 | Completed

• 1 other identifier: 2018-A02934-51
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Keywords

Aging; Skin dryness; Skin elasticity; Hyaluronic acid; Injection; Cheek; Neckline area; Healthy subjects; Intra-individual; Independent evaluators; Prospective; Randomized study

Outcome Measures

Primary Outcomes (1)

• 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®.

  Month 3

Secondary Outcomes (9)

• Variation of cheek cutaneous moisturization

  Month 1, Month 2, Month 4, Month 6, Month 9

• Variation of neckline area cutaneous moisturization

  Month 1, Month 2, Month 3, Month 4, Month 6, Month 9

• Variation of cheek and neckline area cutaneous elasticity

  Month 1, Month 2, Month 3, Month 4, Month 6, Month 9

• Variation of cheek cutaneous roughness

  Month 1, Month 2, Month 3, Month 4, Month 6, Month 9

• Variation of neckline area cutaneous roughness

  Month 1, Month 2, Month 3, Month 4, Month 6, Month 9

Study Arms (2)

Treated cheek and neckline area

EXPERIMENTAL

Intra-individual study with one cheek and one side of neckline area treated

Device: Injection of STYLAGE® HydroMax

Non-treated cheek and neckline area

NO INTERVENTION

Intra-individual study with one cheek and one side of neckline area non-treated

Interventions

Injection of STYLAGE® HydroMax DEVICE

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.

Also known as: Injection of hyaluronic acid gel

Treated cheek and neckline area

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subject.
• Female between 35 and 65 years.
• Having given freely and expressly her informed consent.
• With signs of cutaneous dryness on the cheeks and neckline area (checked by measurements using Corneometer® \<60 arbitrary unit (AU) on each cheek).
• With signs of a mild to moderate lack of elasticity on face and neckline area following investigator assessment.
• Psychologically able to understand the study related information and to give a written informed consent.
• Affiliated to a health social security system.
• Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study.
• Agreeing not to change any hormonal treatment (including contraceptive treatment) during the whole study.
• Agreeing to keep their usual cleansing / care products during the whole study period.
• Agreeing to apply a sun protection factor SFP50 cream during non-intensive exposure to sunlight.

You may not qualify if:

• Pregnant or nursing woman or planning a pregnancy during the study.
• With a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation.
• Who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• In a social or sanitary establishment.
• Having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
• Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
• Suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
• With known history of or suffering from autoimmune disease and/or immune deficiency.
• Having history of severe allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the component of the tested device, antiseptic solution or anaesthesia product if applicable.
• With fructose intolerance.
• With a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats.
• Predisposed to keloids or hypertrophic scarring.
• Prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• Having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the cheeks or the neckline area within the past 12 months prior to study start.
• Having received injection with a resorbable filling product in the cheeks or the neckline area within the past 18 months prior to study start.

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (1)

Laboratoire DERMSCAN

Villeurbanne, Rhône, 69100, France

Location

Study Officials

• Sophie CONVERSET-VIETHEL, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects and injectors will be unblinded. All investigators in charge of clinical examination and assessment of local tolerance, as well as all technicians in charge of measurements of moisturization, elasticity, roughness and management of subject questionnaire will be blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 12, 2019
• Study Start: September 3, 2019
• Primary Completion: January 10, 2020
• Study Completion: July 8, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)