FaceFREENCT04970290
Clinical and Instrumental Evaluation on Definisse Threads
A study testing Definisse threads free floating and definisse threads double needle in people with Face, run by Relife S.r.l. at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Face
- What is being tested?
- Definisse threads free floating and definisse threads double needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Absolute exclusion criteria
- Subjects presenting one or more of the following absolute exclusion criteria will not be eligible to enter the study.
- 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.
Show all 32Show fewer
- 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.
- Subjects with active skin infection (impetigo, herpes simplex, massive demodex folliculorum, Pityrosporum, Propionibacterium acnes, viral warts).
- Obesity.
- Subjects who are hard smokers (more than 19 cigarettes/day).
- 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.
- Subjects with severe ptosis.
- Anxious subjects.
- Subjects with melasma and post-inflammatory hyperpigmentation.
- Subjects with non-infectious gastrointestinal conditions like Crohn's disease or ulcerative colitis.
- Subjects with hypertension, using anti-inflammatory and/or anticoagulant/antiaggregant medications.
- Subjects who received filler injections or neurotoxin injection within the previous 2 months.
- Subjects with inflammatory conditions of the skin.
- Subjects who are mild-moderate smokers.
- Subjects having menstruation during the day of the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Face REshaping Effect With Definisse Threads: Clinical and Instrumental Evaluation ( FREE Study)
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
Read the 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
- Being tested
- Definisse threads free floating and definisse threads double needle
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definisse threads free floating and definisse threads double needleDevice
Definisse threads are two class III medical devices, for evaluate the performance of the reshaping effect of the face at day 30
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Definisse threads free floating and definisse threads double needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days of treatment
Secondary outcomes (7)
reshaping effect between baseline and T15d, T4m, T8m, T12m.
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.))
Measured: 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
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.
Measured: 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)
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).
Measured: 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
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
Measured: 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
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.
Measured: up to 30 days, 4 months, 8 months, 12 months of treatment
To evaluate the global pain perception during the implant procedure at T1d and T15d.
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)).
Measured: up to 1 and 15 days of treatment
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).
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)
Measured: up to 1 day, 15 ddays, 30 days, 4 months, 8 month, 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start6 Nov 2021
- Primary completion21 Feb 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, prospective, open label, uncontrolled, post-market clinical investigation
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relife S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvatore Fundarò, Principal investigator, MULTIMED poliambulatorio and day surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970290
- Sponsor's protocol ID
- ReGl/20/DTh-Rej/002
- Acronym
- FREE
- Status last verified
- Apr 2022
- First submitted
- 23 Jun 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face REshaping Effect With Definisse Threads: Clinical and Instrumental Evaluation ( FREE Study)
- ClinicalTrials.gov ID
- NCT04970290
- Acronym / sponsor ID
- FREE / ReGl/20/DTh-Rej/002
- Conditions
- Face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Relife S.r.l.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, prospective, open label, uncontrolled, post-market clinical investigation
| Arm | Type | Receives |
|---|---|---|
| Definisse threads free floating and Definisse threads double needle | Experimental | Device: Definisse threads free floating and definisse threads double needleDefinisse™ 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (32 listed)
- Absolute exclusion criteria
- Subjects presenting one or more of the following absolute exclusion criteria will not be eligible to enter the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Definisse threads free floating and definisse threads double needleDefinisse threads are two class III medical devices, for evaluate the performance of the reshaping effect of the face at day 30 | Device | Definisse threads free floating and Definisse threads double needle |
Primary outcome
Volume of midface and lower face with Definisse threads double needle and Definisse threads free floating insertion at day 30
Time frame: 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
7 secondary outcomes
reshaping effect between baseline and T15d, T4m, T8m, T12m.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: up to 30 days, 4 months, 8 months, 12 months of treatment
To evaluate the global pain perception during the implant procedure at T1d and T15d.
Time frame: up to 1 and 15 days of treatment
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).
Time frame: up to 1 day, 15 ddays, 30 days, 4 months, 8 month, 12 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Fundarò principal investigator
MULTIMED poliambulatorio and day surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Definisse threads free floating and definisse threads double needle in people with Face, run by Relife S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of midface and lower face with Definisse threads double needle and Definisse threads free floating insertion at day 30 (time frame: up to 30 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.