Face
Conditions
Brief summary
The scope of this clinical trial is to evaluate and confirm thereshaping effect of the face with Definisse Threads double needle and Definisse threads free floating insertion, at day 30. 6 clinical follow up visit will be performed
Detailed description
The scope of this clinical trial is to evaluate and confirm thereshaping effect of the face with Definisse Threads double needle and Definisse threads free floating insertion, at day 30. 6 clinical follow up visit will be performed to evaluate the modification of skin surface characteristics, the reshaping effect of the face, the subject's satisfaction at each visit, the presence/absence of the threads after the implantation and the global pain perception during the implant procedure..
Interventions
DEVICEDefinisse threads free floating and definisse threads double needle
Definisse threads are two class III medical devices, for evaluate the performance of the reshaping effect of the face at day 30
Sponsors
Relife S.r.l.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Monocentric, prospective, open label, uncontrolled, post-market clinical investigation
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Women, aged between 30 and 60 years (inclusive), looking for aesthetic procedures to improve the aspect of their midface and lower face. 2. Caucasian race. 3. Subjects, as per Investigator's assessment, with the degree of laxity in the middle and lower face belonging to 1-7 classes (inclusive), according to the Facial Laxity Rating Scale. 4. Subjects calm and controlled, according to the Investigator's opinion. 5. Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks, side effects and discomforts and willing to adhere to the study schedule (including attendance to the planned visits) and study prescriptions. 6. Written informed consent release prior to any study-related procedures
Exclusion criteria
Absolute
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of midface and lower face with Definisse threads double needle and Definisse threads free floating insertion at day 30 | up to 30 days of treatment | The primary objective of this clinical investigation is to evaluate the reshaping effect of the face with Definisse™ thread double needle and Definisse™ thread free floating insertion, at Day 30, through 3D photos and 2D photos, through VECTRA®H2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the modification of skin surface characteristics at 30 days, 4 months, 8 months and 12 monts from baseline | up to 30 days, 4 months, 8 months and 12 monts of tratment | Modification of skin surface characteristics in terms of wrinkles, pores and texture, that will be evaluated and quantified at day 30d, 4 months, 8 months, 12 months from baseline through ANTERA 3D. |
| to evaluate the subject's satisfaction at each visit (1 day, 15 days, 30 days, 4 months, 8 months and 12 monts) | up to 1 day, 15 days, 30 days, 4 months, 8 monts and 12 months of treatment | Subject's satisfaction self-assessment on the reshaping effect according to the Global Aesthetic Improvement Scale (GAIS: 5-item scale, where 1 = exceptional improvement, 2 = very improved, 3 = improved, 4 = unaltered, 5 = worsened.) at each visit (1 day, 15 days, 30 days, 4 months, 8 months and 12 monts). |
| To assess the clinical evaluation of reshaping effect of the total, middle and lower face comparing baseline to T15d, T30d, T4m, T8m, T12m by the non-treating investigators | up to 15 days, 30 days, 4 months,8 months, 12 months of treatment | Aesthetic changes of the total, middle and lower face according to the Global Aesthetic Improvement Scale (GAIS: 5-item scale, where 1 = exceptional improvement, 2 = very improved, 3 = improved, 4 = unaltered, 5 = worsened) by the non-treating investigators (one plastic surgeon and one dermatologist) as clinical evaluation of reshaping effect, comparing baseline to T15d, T30d, T4m, T8m, T12m, by evaluating the 2D photos collected by VECTRA®H2 |
| reshaping effect between baseline and T15d, T4m, T8m, T12m. | up to 15 days, 4 months, 8 months and 12 monts of tratment | To evaluate the reshaping effect of the face with Definisse™ threads between baseline and day 15, 4 months, 8 months, 12 months with GAIS (Global Aesthetic Improvement Scale; 5-item scale, where 1 = exceptional improvement, 2 = very improved, 3 = improved, 4 = unaltered, 5 = worsened.)) |
| To evaluate the global pain perception during the implant procedure at T1d and T15d. | up to 1 and 15 days of treatment | Global pain perception during the implant procedure at 1 day and at the first follow-up visit (15 days) by a numeric pain scale (NRS: from 0 (No pain) to 10 (worst possible pain)). |
| To evaluate the subject's self-esteem at each visit (1 day, 15 days, 30 days, 4 months, 8 months and 12 monts) T30d, T4m, T8m, T12m). | up to 1 day, 15 ddays, 30 days, 4 months, 8 month, 12 months of treatment | Subject's self-esteem by the Rosenberg Self-Esteem Scale at each visit ( This scale is a widely used self-report instrument for evaluating individual self-esteem. The scale ranges from 0 to 30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.)(1 day, 15 days, 30 days, 4 months, 8 months and 12 monts) |
| To evaluate the presence/absence of the threads after the implantation at T30d, T4m, T8m, T12m | up to 30 days, 4 months, 8 months, 12 months of treatment | Presence/absence of the thread in the implant area after 30 days, 4 months, 8 months and 12 monts from the treatment with an ultrasound evaluation. |
Countries
Italy
Outcome results
None listed