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Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

NCT06774742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-09-24

No results posted yet for this study

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.

Conditions

  • Skin Quality
  • Lips Quality
  • Persistence of the Effect

Interventions

DIETARY_SUPPLEMENT

HAFS Supplementation

1 capsule of HAFS per day

DIETARY_SUPPLEMENT

Placebo

1 capsule of placebo per day

Sponsors & Collaborators

  • TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2025-07-03
Completion
2025-07-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06774742 on ClinicalTrials.gov