Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads (NCT06454994) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads
France70 participantsStarted 2024-06
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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/ hyperse…
What they're measuring
1
Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products