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

TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd1 site in 1 country130 target enrollmentJanuary 2, 2025

ConditionsSkin Quality Lips Quality Persistence of the Effect

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Quality
Sponsor: TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd
Enrollment: 130
Locations: 1
Primary Endpoint: Skin hydration
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2, 2025

End Date

July 3, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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);
•Subject with skin abnormalities (e.g., scars, excessive hair, tattooing) or any dermatosis (e.g., psoriasis, eczema, acne vulgaris) on the face which could interfere with the study;
•Subject having applied any cosmetic product (care cream, lotion, body milk…) or drug on the face (except usual cleansing products) within one week before the study visit (Day 1);

Outcomes

Primary Outcomes

Skin hydration

Time Frame: Change from baseline to 3 months

Facial skin hydration (Corneometer)

Secondary Outcomes

Lip volume(From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end))
Skin barrier function(From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end))
Dermatological assessment of lips(From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end))
Self assessment questionnaire(From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end))
Lip color(From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end))
Lip hydration(From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end))
Dermatological assessment of skin face(From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end))