Clinical study of the safety and effectiveness of two hyaluronic acid injectable products (MaiLi Precise® and MaiLi Define®) as fillers in the treatment of lip thinness and wrinkles around the mouth
| ISRCTN | ISRCTN30768206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30768206 |
| Secondary identifying numbers | 21E1105 |
- Submission date
- 28/03/2022
- Registration date
- 29/03/2022
- Last edited
- 30/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Background and study aims
Procedures on the lips have become increasingly common and their popularity has grown due to cultural trends and the association of lip appearance with both youth and beauty. Many patients desire lips filler injection to improve the fullness and definition of their lips. The aim of this study is to evaluate the effectiveness and safety of MaiLi Precise® and MaiLi Define® for lip augmentation and the correction of wrinkles around the mouth (perioral area).
Who can participate?
People aged 18-65 years seeking an improvement of their lip volume and/or their perioral area
What does the study involve?
Participants are randomly allocated to receive a single injection of MaiLi Precise® or MaiLi Define®. Several follow-up visits will be carried out at Day 14, 1 month, 6 months and 12 months after the treatment assess the safety and effectiveness of the injection.
What are the possible benefits and risks of participating?
The possible benefits are an aesthetic improvement by increasing the volume of lips and/or filling the perioral wrinkles. Potential adverse events can occur. In most cases, those adverse events are naturally resolved within 1 week. In case of an adverse event lasting for more than 1 week, the investigator should assess and define the best course of action.
Where is the study run from?
Cabinet renaissance of Dr Gianfermi (France)
When is the study starting and how long is it expected to run for?
July 2021 to October 2023
Who is funding the study?
Sinclair Pharmaceuticals Limited (UK)
Who is the main contact?
Stuart Boothman
SBoothman@sinclair.com
Contact information
Mr Stuart Boothman
Scientific
Scientific
Sinclair Pharmaceuticals Limited
Eden House
Lakeside Chester Business Park
Chester
CH4 9QZ
United Kingdom
| Phone | +44 (0)1244 625150 |
|---|---|
| SBoothman@sinclair.com |
Study information
| Study design | Prospective open-label interventional intra-individual study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non-randomized study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clinical study of the safety and effectiveness of the use of MaiLi Precise® and MaiLi Define® in the treatment of lips and perioral area |
| Study hypothesis | MaiLi Precise® and MaiLi Define® induce a global aesthetic improvement of the treated area(s). |
| Ethics approval(s) | Approved 25/03/2022, CPP Nord-Ouest II (Bâtiment pharmacie - Hôpital Nord - Place Victor Pauchet 80054 Amiens, France; +33 (0)3 22 66 85 43; cpp.nordouest2@chu-amiens.fr), ref: 21.04692.000042 |
| Condition | For MaiLi Precise® treatment: very thin to thin lip volume and /or moderate to severe perioral wrinkles; for MaiLi Define® treatment: thin to moderate lip volume |
| Intervention | 34 subjects will be included in group 1 and treated with MaiLi Precise®: 1. At least 12 will be treated for lip volume 2. At least 11 will be treated for lip definition 3. At least 11 will be treated in the perioral wrinkles 34 subjects will be included in group 2 and treated with MaiLi Define® for lip volume. Only one injection session is planned. 2 ml maximum per area will be used by the injector. The subjects will be followed up for up to 12 months after treatment. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MaiLi Precise®, MaiLi Define® |
| Primary outcome measure | Aesthetic Improvement measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by an independent live assessor 6 months after treatment (M6) |
| Secondary outcome measures | 1. Aesthetic improvement measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by a live assessor 1 month (M1) and 12 months (M12) after treatment 2. Aesthetic improvement measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by the subjects at M1, M6 and M12 3. Subject's satisfaction measured using an in-house questionnaire at M1, M6 and M12 4. Injector satisfaction measured using an in-house questionnaire at M1 5. Improvement of treated areas measured using Rossi and Bazin scales evaluated by an assessor on photographs at M1, M6 and M12 6. Safety measured using injection site reactions (ISR) rated by a live assessor and by the subjects and by the collection of adverse events after treatment, at M1, M6 and M12 |
| Overall study start date | 13/07/2021 |
| Overall study end date | 01/10/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 68 |
| Total final enrolment | 68 |
| Participant inclusion criteria | 1. Sex: female or male 2. Age: between 18 and 65 years 3. Subject seeking an improvement of her/his lip volume and/or perioral area 4.1. For group 1: subject with very thin to thin lips volume (score 1 to 2 on Rossi scale) and /or subject with moderate to severe perioral wrinkles (score 2 to 6 on the Bazin scale) 4.2. For group 2: subject with thin to moderate lips volume (score 2 to 3 on Rossi scale) 5. Subject having given freely and expressly his/her informed consent 6. Subject willing to have photographs of the face taken and who are willing provide approval for the use of their study data and photographs in published literature 7. Subject willing and able to comply with study follow-up procedures and schedule 8. Subject affiliated to a health social security system 9. Females of childbearing potential should use a medically accepted contraceptive regimen for at least 12 weeks prior to study entry and during the study 10. Subject willing to commit to having no further facial aesthetic treatments below the zygomatic arch for the duration of the study period, including follow-up |
| Participant 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 is an employee of the investigational site, the CRO or the study sponsor 6. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation (tattoo, permanent make-up) 7. Subject with major dental problems 8. Subject under epidemiologic surveillance / in quarantine linked to the COVID-19 pandemic 9. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety 10. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency 11. Subject with porphyria 12. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement) 13. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea) on or around the lips within 6 months of the study entry 14. Subject predisposed to keloids or hypertrophic scarring 15. Subject with a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment 16. Subject with a known history of precancerous lesions/skin malignancies 17. Subject with hypersensitivity or with known allergy to: hyaluronic acid, lidocaine, amide-type local anaesthetics or to one of the components of the tested devices or antiseptic solution 18. Subject with a known history of severe allergy or anaphylactic shock 19. Subject having received any medication which may interfere, at the interpretation of the investigator, with the study objectives in terms of efficacy and safety 20. Subject having received treatment with a laser or UV, dermabrasion, surgery, deep chemical peeling or any other procedure based on active dermal response on/around the lips within the past 6 months 21. Subject received within the past 12 months hyaluronic acid injections (not including this study) on or around the lips 22. Subject received at any time permanent filler (e.g. polylactic acid, PMMA, silicone) on or around the lips 23. Subject received at any time a lip threading surgery 24. Subject received oral surgery (e.g. tooth extraction, orthodontia or implantation) within 6 weeks prior to study entry 25. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit and 1 month after treatment 26. Subject having started or changed his/her oral contraceptive or any other hormonal treatment during 12 weeks prior to study entry |
| Recruitment start date | 25/04/2022 |
| Recruitment end date | 01/10/2022 |
Locations
Countries of recruitment
- France
Study participating centre
Cabinet renaissance
54 rue Voltaire
Levallois Perret
92300
France
Levallois Perret
92300
France
Sponsor information
Sinclair Pharma
Industry
Industry
Eden House
Lakeside Chester Business Park
Chester
CH4 9QZ
England
United Kingdom
| Phone | +44 (0)1244 625150 |
|---|---|
| SBoothman@sinclair.com | |
| Website | http://www.sinclairpharma.co.uk/ |
"ROR" |
https://ror.org/00ab7gt92 |
Funders
Funder type
Industry
Sinclair Pharmaceuticals Limited
No information available
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| 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 |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 30/09/2024 | 30/09/2024 | No | No |
Additional files
Editorial Notes
30/09/2024: Basic results and total final enrolment added.
29/03/2022: Trial's existence confirmed by the CPP Nord-Ouest II.
