Clinical trial NCT06454994: Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads
Official title: A Prospective, Multicentric, Comparative, Split-face Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aesthetic
Keywords: Lifting threads
Eyebrow lift
Jaw laxity
Lead sponsor: GCS Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Eurofins Laboratoire Dermscan
First posted: 2024-06-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Hemi-face, intra-individual study
Primary purpose: OTHER

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products
timeFrame: Month 3
Secondary outcomes:
measure: Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator
timeFrame: Month 3, Month 6, Month 12
measure: Percentages of responders for Global Aesthetic Improvement (GAIS) by the subject
timeFrame: Month 3, Month 6, Month 12
measure: Change from baseline of Facial Laxity Rating Scale (FLRS) score
timeFrame: Month 3, Month 6, Month 12
measure: Percentages of subjects satisfied with the intervention using a subjective evaluation questionnaire
timeFrame: Month 3, Month 6, Month 12
measure: Number and percentages of immediate and early skin reactions collected by the subject
timeFrame: Month 1
measure: Number and percentages of skin reactions scored by the investigator
timeFrame: Month1, Month 3, Month 6, Month 12
measure: Number and percentages of Adverse Events
timeFrame: Month1, Month 3, Month 6, Month 12
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Dr Jeanblanc
city: Cannes
country: France
facility: Dr Facchinetti
city: Lyon
country: France
facility: Dr Converset-Viethel
city: Paris
country: France
facility: Dr Lemmel
Study officials:
References: