NCT06774742

Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

Evaluation of the Effects of a Dietary Supplement Containing a Full Range of Hyaluronic Acids in Healthy Female Subjects With Dry Facial Skin and Lips

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	HAFS Supplementation	1 capsule of HAFS per day
DIETARY_SUPPLEMENT	Placebo	1 capsule of placebo per day

Timeline

• Start date: 2025-01-02
• Primary completion: 2025-07-03
• Completion: 2025-07-03
• First posted: 2025-01-14
• Last updated: 2025-09-24

Locations

1 site across 1 country: France