AestheticNCT06454994
Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads
A study testing Eyebrow lift and Jaw lift in people with Aesthetic, run by GCS Co., Ltd at 4 sites in France.
Trial summary
The aim of this study is to compare two models of the Nobel Lift range (PDO sutures) with similar PDO devices available on the market, in a split-face comparative study. Each thread model will be used in one indication: upper face (eyebrow lift) or mid-face and lower-face. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetic
- What is being tested?
- Eyebrow lift and Jaw lift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 4 sitesFrance
- Study dates
- 5 Jun 2024to 24 Feb 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI comprised between 18.5 and 30
- No ongoing or planned diet.
- Group 1: requiring an aesthetic treatment of upper face with resorbable threads.
- Group 2: Subject requiring an aesthetic treatment of mid-face and lower-face with resorbable threads
- Subject with dense and not too thin skin.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study;
- Suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety, especially cardiac disorder, non-controlled high blood pressure, diabetes, panic disorders, depression, active auto-immune disease, cold, high fever,…
- Suffering from malnutrition.
- Acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
- Wound healing disorder or with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
- History of precancerous lesions/skin malignancies.
Show all 23Show fewer
- Active skin disease within 6 months of study entry.
- Scars, rosacea, herpes, acne, blotches or other pathology in the face, at the investigator appreciation.
- Predisposed to keloidosis or hypertrophic scarring.
- Known history of hyper- or hypo-pigmentation in the face.
- Known history of multiple allergies, allergic/anaphylactic reactions including allergy/ hypersensitivity to lidocaine, anaesthetics of the amide type, the used antiseptic components, the used antibiotic cream components.
- Known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment.
- Extensive skin laxity, thin skin and/or severe malar fat sagging.
- Foreign body sensitivity or known or suspected allergies to implant or instrument materials in particular plastic/biomaterial.
- Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety/tolerance.
- Dental care in the past 2 weeks or who planned to receive dental care in the 2 months after the treatment.
- Anticoagulant (such as aspirin, warfarin, blood circulation enhancer and clotbuster) during the week before the injection session .
- Chemotherapy agents, immunosuppressive medications or systemic corticosteroids in the past 3 months and during the study.
- Lifting of the face in the past 12 months or other surgery of the face in the past 6 months.
- Resorbable fillers within the past 12 months, other resorbable threads within the past 12 months, neurotoxin in the past 5 months or plans to receive such treatments during the study.
- Permanent filler on the face.
- Subcutaneous permanent retaining structure on the face (meshing, permanent threads, gold strand etc.).
- Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Dr Jeanblanc
Aix-en-Provence
Dr Facchinetti
Cannes
Dr Converset-Viethel
Lyon
Dr Lemmel
Paris
About this study
Official title: A Prospective, Multicentric, Comparative, Split-face Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads
The aim of this study is to compare two models of the Nobel Lift range (PDO sutures) with similar PDO devices available on the market, in a split-face comparative study. Each thread model will be used in one indication: upper face (eyebrow lift) or mid-face and lower-face.
Aesthetic efficacy of the devices will be evaluated and compared with the Global Aesthetic Improvement Scale (GAIS), jowl laxity scale, subjective evaluation of the patient and photographs during a 12-months period. Safety of the devices and procedures will also be evaluated.
- Conditions
- Aesthetic
- Being tested
- Eyebrow lift, Jaw lift
- Keywords
- Lifting threads, Eyebrow lift, Jaw laxity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyebrow liftDevice
Upper face lifting
Jaw liftDevice
Mid-face and low-face lifting
| Study group | Role | What they receive |
|---|---|---|
| Noble Lift threads | Experimental | Not described Receives: Device: Eyebrow lift; Device: Jaw lift |
| Croquis threads | Active comparator | Not described Receives: Device: Eyebrow lift; Device: Jaw lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products
Non-inferiority of Noble Lift® threads in comparison with Croquis® thread, in terms of GAIS mean score on Month 3, assessed by an independent blinded investigator on photos (in global and for each indication). GAIS is a scale from 1 (worse) to 5 (very much improved).
Measured: Month 3
Secondary outcomes (7)
Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator
GAIS is a scale from 1 (worse) to 5 (very much improved)
Measured: Month 3, Month 6, Month 12
Percentages of responders for Global Aesthetic Improvement (GAIS) by the subject
GAIS is a scale from 1 (worse) to 5 (very much improved)
Measured: Month 3, Month 6, Month 12
Change from baseline of Facial Laxity Rating Scale (FLRS) score
FLRS is a scale from 1 (mild laxity) to 9 (severe laxity)
Measured: Month 3, Month 6, Month 12
Percentages of subjects satisfied with the intervention using a subjective evaluation questionnaire
Answers are evaluated from 1 (very dissatisfied) to 5 (very satisfied)
Measured: Month 3, Month 6, Month 12
Number and percentages of immediate and early skin reactions collected by the subject
Skin reactions are scored as mild, moderate or severe
Measured: Month 1
Number and percentages of skin reactions scored by the investigator
Skin reactions are scored as mild, moderate or severe
Measured: Month1, Month 3, Month 6, Month 12
Number and percentages of Adverse Events
Measured: Month1, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start5 Jun 2024
- Primary completion24 May 2025
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Hemi-face, intra-individual study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Laboratoire Dermscan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454994
- Sponsor's protocol ID
- 23E1359
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Comparative, Split-face Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads
- ClinicalTrials.gov ID
- NCT06454994
- Acronym / sponsor ID
- 23E1359
- Conditions
- Aesthetic
- Keywords
- Lifting threads, Eyebrow lift, Jaw laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- GCS Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Laboratoire Dermscan
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 24 May 2025 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 12 Jun 2024 (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.
The aim of this study is to compare two models of the Nobel Lift range (PDO sutures) with similar PDO devices available on the market, in a split-face comparative study. Each thread model will be used in one indication: upper face (eyebrow lift) or mid-face and lower-face.
Aesthetic efficacy of the devices will be evaluated and compared with the Global Aesthetic Improvement Scale (GAIS), jowl laxity scale, subjective evaluation of the patient and photographs during a 12-months period. Safety of the devices and procedures will also be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Hemi-face, intra-individual study
| Arm | Type | Receives |
|---|---|---|
| Noble Lift threads | Experimental | Device: Eyebrow lift, Device: Jaw lift |
| Croquis threads | Active comparator | Device: Eyebrow lift, Device: Jaw lift |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI comprised between 18.5 and 30
- No ongoing or planned diet.
- Group 1: requiring an aesthetic treatment of upper face with resorbable threads.
- Group 2: Subject requiring an aesthetic treatment of mid-face and lower-face with resorbable threads
- Subject with dense and not too thin skin.
Key exclusion criteria (23 listed)
- Pregnant or nursing woman or planning a pregnancy during the study;
- Suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety, especially cardiac disorder, non-controlled high blood pressure, diabetes, panic disorders, depression, active auto-immune disease, cold, high fever,…
- Suffering from malnutrition.
- Acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
- Wound healing disorder or with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
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 |
|---|---|---|
| Eyebrow liftUpper face lifting | Device | Croquis threads, Noble Lift threads |
| Jaw liftMid-face and low-face lifting | Device | Croquis threads, Noble Lift threads |
Primary outcome
Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products
Time frame: Month 3
Non-inferiority of Noble Lift® threads in comparison with Croquis® thread, in terms of GAIS mean score on Month 3, assessed by an independent blinded investigator on photos (in global and for each indication). GAIS is a scale from 1 (worse) to 5 (very much improved).
7 secondary outcomes
Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator
Time frame: Month 3, Month 6, Month 12
Percentages of responders for Global Aesthetic Improvement (GAIS) by the subject
Time frame: Month 3, Month 6, Month 12
Change from baseline of Facial Laxity Rating Scale (FLRS) score
Time frame: Month 3, Month 6, Month 12
Percentages of subjects satisfied with the intervention using a subjective evaluation questionnaire
Time frame: Month 3, Month 6, Month 12
Number and percentages of immediate and early skin reactions collected by the subject
Time frame: Month 1
Number and percentages of skin reactions scored by the investigator
Time frame: Month1, Month 3, Month 6, Month 12
Number and percentages of Adverse Events
Time frame: Month1, Month 3, Month 6, Month 12
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyebrow lift and Jaw lift in people with Aesthetic, run by GCS Co., Ltd at 4 sites 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 5 inclusion and 23 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.