Skin QualityNCT06774742
Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid
A study testing HAFS Supplementation in people with Skin Quality and Lips Quality, run by TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Quality, Lips Quality, Persistence of the Effect
- What is being tested?
- HAFS Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to 3 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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);
- Subject impossible to contact in case of emergency;
- Subject who, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state);
- Subject who is in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization;
- Subject who has been deprived of their freedom by administrative or legal decision, or who is under care of a guardian or legal guardianship, or subject hospitalized in a medical or social establishment for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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
- Being tested
- HAFS Supplementation, Placebo
- Keywords
- skin hydration, skin quality, anti-aging, lips hydration, lips volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAFS SupplementationDietary supplement
1 capsule of HAFS per day
PlaceboDietary supplement
1 capsule of placebo per day
| Study group | Role | What they receive |
|---|---|---|
| HAFS Supplementation | Experimental | Hyaluronic acid full spectrum daily supplementation Receives: Dietary Supplement: HAFS Supplementation |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin hydration
Facial skin hydration (Corneometer)
Measured: Change from baseline to 3 months
Secondary outcomes (7)
Lip hydration
Changes in lip hydration (Corneometer®)
Measured: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Lip color
Changes in skin and lip color (Mexameter®)
Measured: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Lip volume
Change from baseline in lip volume (LifeViz®)
Measured: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Skin barrier function
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.
Measured: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Dermatological assessment of skin face
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
Measured: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Dermatological assessment of lips
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
Measured: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Self assessment questionnaire
- Evaluation of the skin face : wrinkle, hydration, firmness, softness, radiance, plump (scores from 0 (not) to 3 (high))
- Evaluation of the lips : hydration, volume, fine lines, color, gloss (scores from 0 being mild and 10 very strong)
- Evaluation of hair quality : volume, growth, loss, strength, radiance (scores from 0 (not) to 3 (high))
- Evaluation of the nail quality : strength, radiance, frailty, growth (scores from 0 (not) to 3 (high))
- Joint health
Measured: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start2 Jan 2025
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Skin QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774742
- Sponsor's protocol ID
- 2024-A01613-44
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Linkov G, Wick E, Kallogjeri D, Chen CL, Branham GH. Perception of upper lip augmentation utilizing simulated photography. Arch Plast Surg. 2019 May;46(3):248-254. doi: 10.5999/aps.2018.01319. Epub 2019 May 15.
PubMed 31113187Stojanovic L, Majdic N. Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies. J Cosmet Dermatol. 2019 Apr;18(2):436-443. doi: 10.1111/jocd.12861. Epub 2019 Jan 12.
PubMed 30636365Day AJ, de la Motte CA. Hyaluronan cross-linking: a protective mechanism in inflammation? Trends Immunol. 2005 Dec;26(12):637-43. doi: 10.1016/j.it.2005.09.009. Epub 2005 Oct 7.
PubMed 16214414Stern R, Asari AA, Sugahara KN. Hyaluronan fragments: an information-rich system. Eur J Cell Biol. 2006 Aug;85(8):699-715. doi: 10.1016/j.ejcb.2006.05.009. Epub 2006 Jul 5.
PubMed 16822580Tavianatou AG, Caon I, Franchi M, Piperigkou Z, Galesso D, Karamanos NK. Hyaluronan: molecular size-dependent signaling and biological functions in inflammation and cancer. FEBS J. 2019 Aug;286(15):2883-2908. doi: 10.1111/febs.14777. Epub 2019 Feb 21.
PubMed 30724463Heldin P, Lin CY, Kolliopoulos C, Chen YH, Skandalis SS. Regulation of hyaluronan biosynthesis and clinical impact of excessive hyaluronan production. Matrix Biol. 2019 May;78-79:100-117. doi: 10.1016/j.matbio.2018.01.017. Epub 2018 Jan 31.
PubMed 29374576Abatangelo G, Vindigni V, Avruscio G, Pandis L, Brun P. Hyaluronic Acid: Redefining Its Role. Cells. 2020 Jul 21;9(7):1743. doi: 10.3390/cells9071743.
PubMed 32708202Stern R. Hyaluronan catabolism: a new metabolic pathway. Eur J Cell Biol. 2004 Aug;83(7):317-25. doi: 10.1078/0171-9335-00392.
PubMed 15503855Michelotti A, Cestone E, De Ponti I, Pisati M, Sparta E, Tursi F. Oral intake of a new full-spectrum hyaluronan improves skin profilometry and ageing: a randomized, double-blind, placebo-controlled clinical trial. Eur J Dermatol. 2021 Dec 1;31(6):798-805. doi: 10.1684/ejd.2021.4176.
PubMed 34933842Hsu TF, Su ZR, Hsieh YH, Wang MF, Oe M, Matsuoka R, Masuda Y. Oral Hyaluronan Relieves Wrinkles and Improves Dry Skin: A 12-Week Double-Blinded, Placebo-Controlled Study. Nutrients. 2021 Jun 28;13(7):2220. doi: 10.3390/nu13072220.
PubMed 34203487Gollner I, Voss W, von Hehn U, Kammerer S. Ingestion of an Oral Hyaluronan Solution Improves Skin Hydration, Wrinkle Reduction, Elasticity, and Skin Roughness: Results of a Clinical Study. J Evid Based Complementary Altern Med. 2017 Oct;22(4):816-823. doi: 10.1177/2156587217743640. Epub 2017 Dec 4.
PubMed 29228816Gao YR, Wang RP, Zhang L, Fan Y, Luan J, Liu Z, Yuan C. Oral administration of hyaluronic acid to improve skin conditions via a randomized double-blind clinical test. Skin Res Technol. 2023 Nov;29(11):e13531. doi: 10.1111/srt.13531.
PubMed 38009035
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06774742
- Acronym / sponsor ID
- 2024-A01613-44
- Conditions
- Skin Quality, Lips Quality, Persistence of the Effect
- Keywords
- skin hydration, skin quality, anti-aging, lips hydration, lips volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- TS Biotech - Shandong Tiansheng Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAFS Supplementation | Experimental | Dietary Supplement: HAFS SupplementationHyaluronic acid full spectrum daily supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAFS Supplementation1 capsule of HAFS per day | Dietary supplement | HAFS Supplementation |
| Placebo1 capsule of placebo per day | Dietary supplement | Placebo |
Primary outcome
Skin hydration
Time frame: Change from baseline to 3 months
Facial skin hydration (Corneometer)
7 secondary outcomes
Lip hydration
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Lip color
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Lip volume
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Skin barrier function
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Dermatological assessment of skin face
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Dermatological assessment of lips
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Self assessment questionnaire
Time frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 31113187Linkov G, Wick E, Kallogjeri D, Chen CL, Branham GH. Perception of upper lip augmentation utilizing simulated photography. Arch Plast Surg. 2019 May;46(3):248-254. doi: 10.5999/aps.2018.01319. Epub 2019 May 15.
- Background: PubMed 30636365Stojanovic L, Majdic N. Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies. J Cosmet Dermatol. 2019 Apr;18(2):436-443. doi: 10.1111/jocd.12861. Epub 2019 Jan 12.
- Background: PubMed 16214414Day AJ, de la Motte CA. Hyaluronan cross-linking: a protective mechanism in inflammation? Trends Immunol. 2005 Dec;26(12):637-43. doi: 10.1016/j.it.2005.09.009. Epub 2005 Oct 7.
- Background: PubMed 16822580Stern R, Asari AA, Sugahara KN. Hyaluronan fragments: an information-rich system. Eur J Cell Biol. 2006 Aug;85(8):699-715. doi: 10.1016/j.ejcb.2006.05.009. Epub 2006 Jul 5.
- Background: PubMed 30724463Tavianatou AG, Caon I, Franchi M, Piperigkou Z, Galesso D, Karamanos NK. Hyaluronan: molecular size-dependent signaling and biological functions in inflammation and cancer. FEBS J. 2019 Aug;286(15):2883-2908. doi: 10.1111/febs.14777. Epub 2019 Feb 21.
- Background: PubMed 29374576Heldin P, Lin CY, Kolliopoulos C, Chen YH, Skandalis SS. Regulation of hyaluronan biosynthesis and clinical impact of excessive hyaluronan production. Matrix Biol. 2019 May;78-79:100-117. doi: 10.1016/j.matbio.2018.01.017. Epub 2018 Jan 31.
- Background: PubMed 32708202Abatangelo G, Vindigni V, Avruscio G, Pandis L, Brun P. Hyaluronic Acid: Redefining Its Role. Cells. 2020 Jul 21;9(7):1743. doi: 10.3390/cells9071743.
- Background: PubMed 15503855Stern R. Hyaluronan catabolism: a new metabolic pathway. Eur J Cell Biol. 2004 Aug;83(7):317-25. doi: 10.1078/0171-9335-00392.
- Results publication: PubMed 34933842Michelotti A, Cestone E, De Ponti I, Pisati M, Sparta E, Tursi F. Oral intake of a new full-spectrum hyaluronan improves skin profilometry and ageing: a randomized, double-blind, placebo-controlled clinical trial. Eur J Dermatol. 2021 Dec 1;31(6):798-805. doi: 10.1684/ejd.2021.4176.
- Results publication: PubMed 34203487Hsu TF, Su ZR, Hsieh YH, Wang MF, Oe M, Matsuoka R, Masuda Y. Oral Hyaluronan Relieves Wrinkles and Improves Dry Skin: A 12-Week Double-Blinded, Placebo-Controlled Study. Nutrients. 2021 Jun 28;13(7):2220. doi: 10.3390/nu13072220.
- Results publication: PubMed 29228816Gollner I, Voss W, von Hehn U, Kammerer S. Ingestion of an Oral Hyaluronan Solution Improves Skin Hydration, Wrinkle Reduction, Elasticity, and Skin Roughness: Results of a Clinical Study. J Evid Based Complementary Altern Med. 2017 Oct;22(4):816-823. doi: 10.1177/2156587217743640. Epub 2017 Dec 4.
- Results publication: PubMed 38009035Gao YR, Wang RP, Zhang L, Fan Y, Luan J, Liu Z, Yuan C. Oral administration of hyaluronic acid to improve skin conditions via a randomized double-blind clinical test. Skin Res Technol. 2023 Nov;29(11):e13531. doi: 10.1111/srt.13531.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAFS Supplementation in people with Skin Quality and Lips Quality, run by TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin hydration (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06774742, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.