Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid (NCT06774742) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid
France130 participantsStarted 2025-01-02
Plain-language summary
This is a single center, double-blind, randomized, placebo-controlled study, performed on two parallel groups.
A total of 130 adult female subjects meeting specific inclusion/exclusion criteria will be included in order to have 120 subjects who complete the study at Day 98/Week 14.
Subjects will be randomly assigned to either the FS-HA oral supplementation group (60 subjects) or the placebo group (60 subjects).
The subjects should agree to attend a total of five (5) visits as follows:
* a screening visit within 21 days prior to Day 1 (from Day -22 to Day -1);
* a baseline visit (Day 1);
* two (2) intermediate visits (Day 29 and Day 84);
* a follow-up and end-of- study visit on Day 98.
The primary objective of this study is to evaluate the effects of an oral supplementation containing a FS-HA on facial skin hydration after 3 months of use, compared with Placebo.
The Secondary Objective(s) will evaluate the effects of an oral supplementation containing a FS-HA compared with Placebo on:
* the hydration of the lips using corneometry;
* the skin quality of the face using dermatological assessments and biophysical measurements (TEWL and Mexametry);
* the quality/health and beauty of the lips using dermatological assessments and biophysical measurements (Mexametry);
* the volume of the lips using image analysis;
* to assess the persistence of the effects 2 weeks after discontinuation;
* to assess the subject perceived efficacy and acceptability (subject self-assessment);
* to evaluate the safety of the study products.
Who can participate
Age range
40 Years – 70 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
. Subject having signed an Informed Consent Form (ICF) before any trial related activity is carried out;
. Female subject;
. Subject aged 40 to 70 years inclusive at the time of signing the ICF;
. Subject with thin and dry lips;
. Subject with dry skin measured on the cheeks (corneometry \< 50);
. Female subject of childbearing potential must use one of the reliable methods of contraception during the investigation and agree not to change it during the study;
. Subject willing and able to follow all the study procedures and restrictions and complete the whole study phase;
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.
. Subject affiliated to a health social security system (according to French Law).
Exclusion criteria
. Female subject who is pregnant or who is breast feeding;
. Female subject of childbearing potential with positive urine pregnancy test at the study visit (Day 1);
. Women with a BMI ≤ 17 or ≥ 32 kg/cm²;
. Subject with any uncontrolled diseases such as diabetes, hypertension, hyperthyroidism or hypothyroidism;
. Presenting or having a history of eating disorder (e.g. anorexia, food allergy) or gastro-intestinal malabsorption such as celiac disease, Crohn's disease, lactose intolerance;
. Subject with an history of sleeve or bypass
. Subject with current participation in any other interventional clinical study, based on interview of the subject;
. Subject with known or suspected hypersensitivity to any component(s) of the investigational products or to any ingredients of the vehicles (i.e., excipients);