CPCAD Hôpital L'Archet 2
Nice, 06200, France
NCT Number: NCT06774742
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.
Looking for future studies?
Notify Me40 year–70 year
Female
Interventional
Not applicable
Nice, 06200, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 capsule of HAFS per day
1 capsule of placebo per day
Time frame: Change from baseline to 3 months
Facial skin hydration (Corneometer)
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Changes in lip hydration (Corneometer®)
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Changes in skin and lip color (Mexameter®)
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Change from baseline in lip volume (LifeViz®)
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
The measurement of the TEWL gives an indication of the integrity of the barrier function of the stratum corneum.
The TEWL will be measured on the face at each evaluation visit using a Vapometer SWL-2 (Delfin, technologies, Kuopio, Finland). This portable device contains moisture sensors in a closed chamber type probe. The conditions of a closed chamber are created by contact with the skin surface (surface of the chamber =1 cm²). The TEWL measurement is expressed in g/m²/h after a stabilization time of 10 to 20 seconds.
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Scoring system for the assessment of the skin face
Skin dryness : 0= no dryness to 9= very dry skin Skin roughness : 0= no roughness to 9= severe roughness Skin evenness : 0= not even at all to 9= very even Skin suppleness : 0= not supple at all to 9= very supple skin Skin elasticity : 0= no elasticity at all to 9= maximal elasticity Skin firmness 0= no firm at all to 9= very firm Skin plumping 0= not plump at all to 9= very plump
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
At each evaluation visit, the lip qualities will be assessed by the Investigator/evaluator using the following 6-point scoring system from 0 to 5.
Lips fullness 0= very thin to 5= very full Lips dryness 0= no dryness to 5= very dry lips Lips roughness 0= no roughness to 5= severe roughness
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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