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 range40 Years – 70 Years
SexFEMALE
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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;
✓. 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);