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

NCT06454994 | Not Yet Recruiting

• 1 other identifier: 23E1359
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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

Keywords

Lifting threads; Eyebrow lift; Jaw laxity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator

  Month 3, Month 6, Month 12

• Percentages of responders for Global Aesthetic Improvement (GAIS) by the subject

  Month 3, Month 6, Month 12

• Change from baseline of Facial Laxity Rating Scale (FLRS) score

  Month 3, Month 6, Month 12

• Percentages of subjects satisfied with the intervention using a subjective evaluation questionnaire

  Month 3, Month 6, Month 12

• Number and percentages of immediate and early skin reactions collected by the subject

  Month 1

Study Arms (2)

Noble Lift threads

EXPERIMENTAL

Device: Eyebrow lift; Device: Jaw lift

Croquis threads

ACTIVE COMPARATOR

Device: Eyebrow lift; Device: Jaw lift

Interventions

Eyebrow lift DEVICE

Upper face lifting

Croquis threads; Noble Lift threads

Jaw lift DEVICE

Mid-face and low-face lifting

Croquis threads; Noble Lift threads

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Co., Ltd: lead
• Eurofins Laboratoire Dermscan: collaborator

Study Sites (4)

Dr Jeanblanc

Aix-en-Provence, France

Location

Dr Facchinetti

Cannes, France

Location

Dr Converset-Viethel

Lyon, France

Location

Dr Lemmel

Paris, France

Location

Central Study Contacts

Audrey Natalizio

CONTACT

+33 4 72 82 36 56; audrey.natalizio@cpt.eurofinseu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Hemi-face, intra-individual study

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)