Clinical and Instrumental Evaluation on Definisse Threads

Not Applicable

Completed

• Conditions: Face
• Interventions: Device: Definisse threads free floating and definisse threads double needle

• Registration Number: NCT04970290
• Lead Sponsor: Relife S.r.l.

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..

Study Timeline

• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-21
• Study Start: 2021-11-06
• Status Verified: 2022-04
• Primary Completion: 2023-02-21
• Study Completion: 2023-06-15
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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 exclusion criteria

Subjects presenting one or more of the following absolute exclusion criteria will not be eligible to enter the study.

1. Pregnant and breast-feeding women.
2. Subjects affected by body dysmorphic disorders.
3. Subjects with known allergy/hypersensitivity to threads components and/or lidocaine and/or clarithromycin.
4. Subjects with chronic urticaria.
5. Subjects with Quincke's edema.
6. Subjects with facial plastic surgery within previous 2 years.
7. Subjects with haemostatic or coagulation disorders (haemophilia, haemoglobin pathology, thalassemia major).
8. Subjects with active localized infection (ear, nose, or throat infections, dental abscess, periodontitis), active generalized infection (gastroenteritis, urinary bladder infection) or systemic infection (example: tuberculosis).
9. Subjects with generalized skin conditions or connective tissue disease (prominent scars, keloid, bullous diseases, cutaneous collagenosis, active psoriasis, connective tissue diseases).
10. Subjects with parotid hypertrophy.
11. Immunocompromised, oncological, diabetic subjects or with active Hashimoto's disease.
12. Subjects who underwent dental procedures within previous 2 weeks.
13. Subjects with conditions potentially causing a Koebner response.
14. Subjects with surgical medical treatments previously performed in the implant area or in the surrounding areas within previous 2 months.
15. Subjects with permanent or semi-permanent implants in the area that will be treated.
16. Subjects with active skin infection (impetigo, herpes simplex, massive demodex folliculorum, Pityrosporum, Propionibacterium acnes, viral warts).
17. Obesity.
18. Subjects who are hard smokers (more than 19 cigarettes/day).
19. Any other clinical condition that upon the judgement of the Investigator contraindicates the treatment with threads.

Relative exclusion criteria

Subjects presenting with one or more of the following relative exclusion criteria will be eligible to enter the study on the basis of the Investigator's evaluation.

1. Subjects with severe ptosis.
2. Anxious subjects.
3. Subjects with melasma and post-inflammatory hyperpigmentation.
4. Subjects with non-infectious gastrointestinal conditions like Crohn's disease or ulcerative colitis.
5. Subjects with hypertension, using anti-inflammatory and/or anticoagulant/antiaggregant medications.
6. Subjects who received filler injections or neurotoxin injection within the previous 2 months.
7. Subjects with inflammatory conditions of the skin.
8. Subjects who are mild-moderate smokers.
9. Subjects having menstruation during the day of the treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definisse threads free floating and Definisse threads double needle	Definisse threads free floating and definisse threads double needle	Definisse™ free floating threads will be used with the Soft Tissue Reshaping-2 (STR-2) Technique, to reposition the tissue of the malar area. It is to be used for the face and neck. The thread presents a central area, free of barbs, and two distal areas with barbs. The 12 cm thread will be used in this study. Definisse™ double needle thread (12 cm) that is equipped with barbs in the intermediate section, while the side and the central sections are smooth. The thread ends with two straight cut edge needles 10 cm long Definisse™ double needle threads will be used with the Jawline Reshaping (JR) Technique, to reshape the frame of the jawline, lifting the lower face. This is to be used for the face and the neck. The thread ends with two straight cut edge needles The 12 cm thread will be used in this study.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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 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
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 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)

Trial Locations

Locations (1)

MULTIMED poliambulatorio and day surgery; 🇮🇹 Bologna, Italia, Italy