The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Ela… (NCT04088006) | Clinical Trial Compass
CompletedNot Applicable
The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity
France47 participantsStarted 2019-09-03
Plain-language 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.
Who can participate
Age range
35 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.