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

NCT ID: NCT06454994

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-12-31

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.

Conditions

Aesthetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Noble Lift threads

Group Type: EXPERIMENTAL

Eyebrow lift

Intervention Type: DEVICE

Upper face lifting

Jaw lift

Intervention Type: DEVICE

Mid-face and low-face lifting

Croquis threads

Group Type: ACTIVE_COMPARATOR

Eyebrow lift

Intervention Type: DEVICE

Upper face lifting

Jaw lift

Intervention Type: DEVICE

Mid-face and low-face lifting

Interventions

Eyebrow lift

Upper face lifting

Intervention Type: DEVICE

Jaw lift

Mid-face and low-face lifting

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eurofins Laboratoire Dermscan

UNKNOWN

Sponsor Role: collaborator

GCS Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr Jeanblanc

Aix-en-Provence, , France

Dr Facchinetti

Cannes, , France

Dr Converset-Viethel

Lyon, , France

Dr Lemmel

Paris, , France

Countries

France

Central Contacts

Audrey Natalizio

Role: CONTACT

audrey.natalizio@cpt.eurofinseu.com

+33 4 72 82 36 56

Facility Contacts

Gérard Jeanblanc

Role: primary

Jean-Marc Facchinetti

Role: primary

Sophie Converset-Viethel

Role: primary

Christian Lemmel

Role: primary

Other Identifiers

23E1359

Identifier Type: -

Identifier Source: org_study_id