Clinical study to evaluate the effectiveness and safety of an implantable suture on the face for the treatment of sagging skin and wrinkles
| ISRCTN | ISRCTN33480483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33480483 |
| Secondary identifying numbers | 19E2210 |
- Submission date
- 14/12/2021
- Registration date
- 14/01/2022
- Last edited
- 16/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Silhouette Soft® is a resorbable sterile suture that is implanted by a physician on the face and neck for aesthetic purposes. The aim of this study is to find out whether implantation of the suture lifts the skin and improves wrinkles and skin sagging. Silhouette Soft® sutures have been on the European market since 2012.
Who can participate?
People aged 35-50 years with moderate to severe nasolabial folds (wrinkles that form alongside the inner cheeks) and mild to moderate skin laxity (looseness) seeking an improvement of wrinkle severity and skin quality on the mid-face
What does the study involve?
The study involves the implantation of several sutures in the mid-face and chin at the initial visit. The number of sutures is determined by the physician according to the nasolabial fold severity. Several follow-up visitswill be carried out at 7 days, 1 month, 9 months, 12 months and 18 months after implantation to assess the safety and effectiveness of the product.
What are the possible benefits and risks of participating?
The possible benefit is an aesthetic improvement of the face. Like all procedures of this type there is a possibility of adverse events, although not everybody experiences them. These adverse events include infection, minimal acute inflammatory tissue reaction, pain (which may be temporary or persistent in nature), swelling and oedema, transient haematoma (collection of blood) or bruising and transient rippling or dimple formation. Other potential adverse events include ecchymosis (bruising), sensory/motor nerve injury, asymmetry, banding, suture migrations and palpable thread ends/knots. Material sensitivity/allergic reactions may occur.
Where is the study run from?
Eurofins Pharmascan (France)
When is the study starting and how long is it expected to run for?
February 2020 to August 2023
Who is funding the study?
Sinclair Pharmaceuticals Limited (UK)
Who is the main contact?
John Meadows
JMeadows@sinclairpharma.com
Contact information
Scientific
Sinclair Pharmaceuticals Limited
Eden House
Lakeside Chester Business Park
Chester
CH4 9QZ
United Kingdom
| Phone | +44 (0)7799 836657 |
|---|---|
| Jmeadows@sinclairpharma.com |
Study information
| Study design | Prospective interventional single-center clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A prospective, single-center, clinical study to evaluate the efficacy and safety of silhouette soft suture as a treatment of nasolabial folds and jowl laxity |
| Study objectives | Silhouette Soft® induces an improvement of the nasolabial folds in more than 50% of the treated population. |
| Ethics approval(s) | Approved 29/06/2021, CPP Ile de France XI (Pavillon Jacques Courtois, 2e étage, 20 rue Amargis, 78105 Saint Germain en Laye Cedex; +33 (0)1 39 27 42 58; cppidf11.chips@ght-yvelinesnord.fr), ref: 21041-69309 |
| Health condition(s) or problem(s) studied | Moderate to severe nasolabial folds severity and mild to moderate skin laxity |
| Intervention | 24 subjects will be included in total and treated with Silhouette Soft® (SMS 22, SMS 23 and SMS 26). The number of sutures to be implanted depends on the naslabial fold severity. Sutures are implanted on the mid-face and chin by a surgeon once at the beginning of the study. The overall duration of the study is 21 months (including screening period and 18 months of follow-up) |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Silhouette Soft®: Silhouette Soft 8 cones (SMS 22), Silhouette Soft 12 cones (SMS 23 and 26) |
| Primary outcome measure | Nasolabial folds severity is measured using the Wrinkles Severity Rating Scale (WSRS) by a live evaluator, 9 months after implantation of the device |
| Secondary outcome measures | 1. Nasolabial folds severity is measured using the Wrinkles Severity Rating Scale (WSRS) by a live evaluator 4, 12 and 18 months after implantation of the device 2. Jawline laxity is measured using the Facial Laxity Rating (FLR) scale by a live evaluator 4, 9, 12 and 18 months after implantation of the device 3. Nasolabial folds severity is measured using Wrinkles Severity Rating Scale (WSRS) by an independent evaluator on photographs 4, 9, 12 and 18 months after implantation of the device 4. Jawline laxity is measured using the Facial Laxity Rating (FLR) scale by an independent evaluator on photographs 4, 9, 12 and 18 months after implantation of the device 5. Nasolabial folds depth and volume are measured using Facial Laxity Rating (FLR) scalefringe projection system (Dermatop) 4, 9, 12 and 18 months after implantation of the device 6. Skin quality is measured using Dermascan, Cutometer and Dermatop 4, 9, 12 and 18 months after implantation of the device 7. Skin collagenesis is measured by analysis of biopsies taken at the level of the suture samples implanted under the chin 4, 9, 12 and 18 months after implantation of the device 8. Global aesthetic measurement is measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by the subjets 4, 9, 12 and 18 months after implantation of the device 9. Physician satisfaction is measured using a questionnaire completed after device implantation on D0 10. Subjects satisfaction is measured using a questionnaire 4, 9, 12 and 18 months after implantation of the device 11. Safety is measured using a cutaneous reaction scale rated by a live evaluator and by the subjects and by the collection of adverse events until 18 months after implantation of the device |
| Overall study start date | 21/02/2020 |
| Completion date | 15/08/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key inclusion criteria | 1. Healthy subject 2. Sex: male or female 3. Age: between 35 and 50 years 4. Subject with a BMI comprised between 18.5 and 30 kg/m² 5. Subject with no ongoing or planned diet 6. Subject with moderate to severe nasolabial folds as determined by a WSRS score of 3 to 4 in both folds (balanced ratio) 7. Subject with a mild to moderate skin laxity as determined by an FLR score of 3 to 6 on both sides of the face 8. Subject with dense and not too thin skin 9. Subject seeking for an improvement of their wrinkle’s severity and skin quality on the mid-face by an aesthetic procedure 10. Subject having given freely and expressly his/her informed consent 11. Subject willing and able to comply with study follow-up procedures and schedule 12. Subject affiliated to a health social security system 13. Females of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks before the beginning of the study and during all the study |
| Key exclusion criteria | 1. Pregnant or nursing woman or planning a pregnancy during the study 2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship 3. Subject in a social or sanitary establishment 4. Subject suspected to be non-compliant according to the investigator’s judgment 5. Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study 6. Subject enrolled in another clinical trial or which exclusion period is not over 7. Subject suffering from a serious or progressive disease, which, in the investigator’s judgment, puts the subject at undue risk (e.g. diabetes, autoimmune pathology, cardiac pathologies (Coronary heart failure, ventricular rhythm disturbances, severe hypertension, obstructive cardiomyopathy), hyperthyroidism, hepatic deficiency, epilepsy, porphyria) 8. Subject has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events 9. Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder 10. Subject has a history of precancerous lesions/skin malignancies 11. Subject with active skin disease within 6 months of study entry 12. Subject with scars, rosacea, herpes, acne, blotches or other pathology in the mid-face, at the investigator appreciation 13. Subject predisposed to keloidosis or hypertrophic scarring 14. Subject with known history of hyper- or hypo-pigmentation in the mid-face 15. Subject has a known history of multiple allergies, allergic/anaphylactic reactions including hypersensitivity to lidocaine, anaesthetics of the amide type, sulfites or the used antiseptic components (chlorhexidine and quaternary ammonium), to the antibiotics of tetracycline family or to lanoline or wool fat 16. Subject has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment 17. Subject with extensive skin laxity, thin skin and/or severe malar fat sagging |
| Date of first enrolment | 02/09/2021 |
| Date of final enrolment | 15/02/2022 |
Locations
Countries of recruitment
- France
Study participating centre
Villeurbanne
69100
France
Sponsor information
Industry
Eden House
Lakeside Chester Business Park
Chester
CH4 9QZ
England
United Kingdom
| Phone | +44 (0)20 7467 6920 |
|---|---|
| info@sinclairpharma.com | |
| Website | http://www.sinclairpharma.co.uk/ |
"ROR" |
https://ror.org/00ab7gt92 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Additional documents are not available. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because this is not needed by the sponsor. The sponsor will only establish a global database with all participants data. Data will be kept by the site for 1 year after the end of the trial, then data will be archived for 15 years by a CRO’s subcontractor |
Editorial Notes
16/12/2021: Trial's existence confirmed by the CPP Ile de France XI.
