Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aesthetic
• Intervention / Treatment: Device: Eyebrow lift; Device: Jaw lift

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audrey Natalizio; Phone Number: +33 4 72 82 36 56; Email: audrey.natalizio@cpt.eurofinseu.com

Study Locations

• France
  • Aix-en-Provence, France
    • Dr Jeanblanc
    • Contact: Gérard Jeanblanc
  • Cannes, France
    • Dr Facchinetti
    • Contact: Jean-Marc Facchinetti
  • Lyon, France
    • Dr Converset-Viethel
    • Contact: Sophie Converset-Viethel
  • Paris, France
    • Dr Lemmel
    • Contact: Christian Lemmel
    • Sub-Investigator: Jean-Jacques Deutsch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noble Lift threads	Device: Eyebrow lift; Upper face lifting; Device: Jaw lift; Mid-face and low-face lifting
Active Comparator: Croquis threads	Device: Eyebrow lift; Upper face lifting; Device: Jaw lift; Mid-face and low-face lifting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and percentages of Adverse Events		Month1, Month 3, Month 6, Month 12
Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator	GAIS is a scale from 1 (worse) to 5 (very much improved)	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)	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)	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)	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	Month 1
Number and percentages of skin reactions scored by the investigator	Skin reactions are scored as mild, moderate or severe	Month1, Month 3, Month 6, Month 12

Collaborators and Investigators

• Sponsor: GCS Co., Ltd
• Collaborators: Eurofins Laboratoire Dermscan

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Lifting threads; Eyebrow lift; Jaw laxity
• Other Study ID Numbers: 23E1359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No