Clinical trial NCT04970290: Clinical and Instrumental Evaluation on Definisse Threads
Official title: Face REshaping Effect With Definisse Threads: Clinical and Instrumental Evaluation ( FREE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Face
Lead sponsor: Relife S.r.l.
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 28
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric, prospective, open label, uncontrolled, post-market clinical investigation
Primary purpose: TREATMENT

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..

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:

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.

Primary outcomes:
measure: Volume of midface and lower face with Definisse threads double needle and Definisse threads free floating insertion at day 30
timeFrame: up to 30 days of treatment
Secondary outcomes:
measure: reshaping effect between baseline and T15d, T4m, T8m, T12m.
timeFrame: up to 15 days, 4 months, 8 months and 12 monts of tratment
measure: To evaluate the modification of skin surface characteristics at 30 days, 4 months, 8 months and 12 monts from baseline
timeFrame: up to 30 days, 4 months, 8 months and 12 monts of tratment
measure: to evaluate the subject's satisfaction at each visit (1 day, 15 days, 30 days, 4 months, 8 months and 12 monts)
timeFrame: up to 1 day, 15 days, 30 days, 4 months, 8 monts and 12 months of treatment
measure: 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
timeFrame: up to 15 days, 30 days, 4 months,8 months, 12 months of treatment
measure: To evaluate the presence/absence of the threads after the implantation at T30d, T4m, T8m, T12m
timeFrame: up to 30 days, 4 months, 8 months, 12 months of treatment
measure: To evaluate the global pain perception during the implant procedure at T1d and T15d.
timeFrame: up to 1 and 15 days of treatment
measure: 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).
timeFrame: up to 1 day, 15 ddays, 30 days, 4 months, 8 month, 12 months of treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: MULTIMED poliambulatorio and day surgery
state: Italia
Study officials:
affiliation: MULTIMED poliambulatorio and day surgery
name: Salvatore Fundarò
role: PRINCIPAL_INVESTIGATOR
References: