Clinical and Instrumental Evaluation on Definisse Threads

NCT ID: NCT04970290

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-06
• Study Completion Date: 2023-06-15

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..

Conditions

Face

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Definisse threads free floating and definisse threads double needle

Intervention Type: DEVICE

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

Interventions

Definisse 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

Intervention Type: DEVICE

Eligibility Criteria

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

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.

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Relife S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore Fundarò

Role: PRINCIPAL_INVESTIGATOR

MULTIMED poliambulatorio and day surgery

Locations

MULTIMED poliambulatorio and day surgery

Bologna, Italia, Italy

Countries

Italy

Other Identifiers

ReGl/20/DTh-Rej/002

Identifier Type: -

Identifier Source: org_study_id