Clinical and Instrumental Evaluation on Definisse Threads

NCT04970290 | Completed

• 1 other identifier: ReGl/20/DTh-Rej/002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Face

Outcome Measures

Primary Outcomes (1)

• Volume of midface and lower face with Definisse threads double needle and Definisse threads free floating insertion at day 30

  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

  up to 30 days of treatment

Secondary Outcomes (7)

• 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 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

• 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

• 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

• 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

Study Arms (1)

Definisse threads free floating and Definisse threads double needle

EXPERIMENTAL

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.

Device: Definisse threads free floating and definisse threads double needle

Interventions

Definisse threads free floating and definisse threads double needle DEVICE

Definisse threads are two class III medical devices, for evaluate the performance of the reshaping effect of the face at day 30

Definisse threads free floating and Definisse threads double needle

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women, aged between 30 and 60 years (inclusive), looking for aesthetic procedures to improve the aspect of their midface and lower face.
• Caucasian race.
• 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.
• Subjects calm and controlled, according to the Investigator's opinion.
• 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.
• Written informed consent release prior to any study-related procedures

You may not qualify if:

• Pregnant and breast-feeding women.
• Subjects affected by body dysmorphic disorders.
• Subjects with known allergy/hypersensitivity to threads components and/or lidocaine and/or clarithromycin.
• Subjects with chronic urticaria.
• Subjects with Quincke's edema.
• Subjects with facial plastic surgery within previous 2 years.
• Subjects with haemostatic or coagulation disorders (haemophilia, haemoglobin pathology, thalassemia major).
• 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).
• Subjects with generalized skin conditions or connective tissue disease (prominent scars, keloid, bullous diseases, cutaneous collagenosis, active psoriasis, connective tissue diseases).
• Subjects with parotid hypertrophy.
• Immunocompromised, oncological, diabetic subjects or with active Hashimoto's disease.
• Subjects who underwent dental procedures within previous 2 weeks.
• Subjects with conditions potentially causing a Koebner response.
• Subjects with surgical medical treatments previously performed in the implant area or in the surrounding areas within previous 2 months.
• Subjects with permanent or semi-permanent implants in the area that will be treated.

Sponsors & Collaborators

• Relife S.r.l.: lead

Study Sites (1)

MULTIMED poliambulatorio and day surgery

Bologna, Italia, 40129, Italy

Location

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvatore Fundarò

  MULTIMED poliambulatorio and day surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Monocentric, prospective, open label, uncontrolled, post-market clinical investigation

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 21, 2021
• Study Start: November 6, 2021
• Primary Completion: February 21, 2023
• Study Completion: June 15, 2023
• Last Updated: June 22, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)