Safety and effectiveness clinical evaluation of the range of injectable hyaluronic acid medical devices in facial aesthetic treatment
| ISRCTN | ISRCTN49836437 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49836437 |
| Secondary identifying numbers | 21E0717 |
- Submission date
- 07/04/2021
- Registration date
- 12/04/2021
- Last edited
- 09/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
Increasing numbers of people are seeking methods to counteract the ageing process. Higher patient expectations are increasing the demand to achieve a natural, rejuvenated and youthful appearance. Hyaluronic acid is a naturally occurring molecule present in the dermis (the thickest layer of the skin). Injecting a medical device gel containing hyaluronic acid helps to counteract the effects of ageing. The aim of this study is to evaluate the clinical performance and safety of a range of dermal fillers named Kysense® until 12 or 18 months after a single injection.
Who can participate?
People aged 18-65 seeking an improvement of their face
What does the study involve?
The study involves a single injection of Kysense dermal filler to treat one area of the face. Several follow-up visits at 1 month, 6 months, 12 months and 18 months will be carried out to assess the safety and performance of the injection.
What are the possible benefits and risks of participating?
The possible benefits are the rejuvenation of the treated area, improving self-esteem and self-confidence. Potential adverse events can occur. In most cases, those adverse events are naturally resolved within 1 week. In case of an adverse event persisting for more than 1 week, the investigator should assess and define the best course of actions.
Where is the study run from?
Eurofin Dermscan Pharmascan (France)
When is the study starting and how long is it expected to run for?
March 2021 to June 2023
Who is funding the study?
Kylane Laboratoires SA (Switzerland)
Who is the main contact?
Compliance@kylane.com
Contact information
Dr Basste Hadjab
Scientific
Scientific
Chemin du pré-fleur 1-3
Plan Les Ouates
1228
Switzerland
| Phone | +33 (0)601780449 |
|---|---|
| b.hadjab@kylane.com |
Study information
| Study design | Open intra-individual single-dose single-center study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Safety and effectiveness clinical evaluation of the range of Kysense® injectable medical devices in facial aesthetic treatment |
| Study objectives | The purpose of this clinical study is to evaluate the clinical performance and safety of the whole range of Kysense® products over a period of 12 or 18 months after a single injection in the context of a post market clinical study. |
| Ethics approval(s) | Approval pending, CPP Nord-Ouest IV (Bâtiment ex-USNB, 6 rue du Professeur Laguesse, CHRU Lille, CS 70001, 59037 Lille Cedex; +33 (0)3 20 44 41 65; cppnordouestiv@univ-lille.fr), ref: 21.04.08.34903 |
| Health condition(s) or problem(s) studied | Moderate to severe peri-oral lines, moderate to severe nasolabial folds, moderate to severe cheeks/cheekbones volume deficit, chin recursion |
| Intervention | The objective of the study is to collect post-marketing data on the safety and effectiveness of the Kysense® range used on different facial injection sites. Four subgroups will be included in this study. The safety profile will be evaluated using the clinical evaluation of the injection site reaction and by collecting adverse events at different time points. The effectiveness will be assessed by evaluating the Global Aesthetic Improvement rated by the subject and independent assessor at different time points. Injectors satisfaction and illustration of the device effectiveness will be collected. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Kysense® range |
| Primary outcome measure | The effectiveness of the Kysense® range used on different treated zones assessed using a clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent assessor at 1 month (T1) after treatment |
| Secondary outcome measures | 1. The effectiveness of the Kysense® range used on different treated zones assessed using a clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent assessor at 6 months (T6), 12 months (T12) and 18 months (T18) 2. Safety assessed using clinical evaluation of the Injection Site Reactions (ISR) rated by the subject and the assessor, and by the collection of adverse events at T1, T6, T12 month + T18 month for a part of the population (groups 3 & 4) 3. Subject’s satisfaction and subject’s opinion on aesthetic improvement on the different treated zones using clinical evaluation of the global aesthetic improvement (GAIS) at T1, T6, T12 month + T18 months for a part of the population (groups 3 & 4) 4. The injector's satisfaction with the injection quality measured using a subjective evaluation questionnaire at the injection visit 5. Device effectiveness assessed using face macrophotographs at the injection visit, 1 month, 6 months, 12 months and 18 months if applicable |
| Overall study start date | 14/03/2021 |
| Completion date | 05/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 68 |
| Key inclusion criteria | 1. Subject seeking an improvement of her/his face aspect with HA filler 2. For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) 3. For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on WSRS scale) 4. For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale) 5. For group 4: Subject seeking improvement of chin retrusion 6. Subject with a stable weight since the last 6 months and who agree to keep a stable weight during the study 7. Subject, having given freely and expressly his/her informed consent 8. Subject psychologically able to understand the study-related information and to give a written informed consent 9. Subject affiliated to a health social security system 10. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks and during all the study |
| Key exclusion criteria | In terms of population: 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 research involving human beings in the 12 previous months, including participation in the present study 6. Subject enrolled in another study or which exclusion period is not over 7. Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make-up) In terms of associated pathology: 8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety 9. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency 10. Subject suffering from an active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea, porphyria) in the 6 months before the screening visit. Subjects with a history of herpes are not eligible even if asymptomatic at the time of inclusion 11. Subject with a history of streptococcal disease or an active streptococcus infection 12. Subject prone to develop inflammatory skin conditions or having a tendency to bleeding disorders 13. Subject predisposed to keloids or hypertrophic scarring or having healing disorders 14. Subject with a history of severe allergy or anaphylactic shock including known hypersensitivity to one of the ingredients of the investigational device (i.e. hyaluronic acid), to antiseptic solution or to amide-type anaesthetics Relating to previous or ongoing treatment: 15. Any medication which may interfere, at the interpretation of the investigator, with the study objectives 16. Subject having received treatment with a laser, dermabrasion, surgery, chemical peeling or any other procedure based on active dermal response on the face within the past 6 months or who plans to undergo any of these procedures during the study 17. Subject having received within the past 18 months or planning to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., hyaluronic acid, CaHA) or neurotoxin on or near the treated zone 18. Subject having received at any time or plans to receive during the study a permanent filler (e.g., polylactic acid, PMMA, silicone) on the face 19. Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand) 20. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit or being a chronic user 21. Subject undergoing a topical treatment on the test area or a systemic treatment: 21.1. Anti-inflammatory medication and/or antihistamines within the past 2 weeks and during the study 21.2. Corticosteroids within the past 2 weeks and during the study 21.3. Retinoids and/or immunosuppressors within the past 3 months and during the study In terms of lifestyle: 22. Intensive exposure to sunlight or UV rays within the previous month and/or foreseen during the study 23. Subject planning to change her/his life habits during the study 24. Excessive consumption of alcohol (more than two glasses of wine per day) and/or tobacco (more than 10 cigarettes per day) |
| Date of first enrolment | 05/06/2021 |
| Date of final enrolment | 30/09/2021 |
Locations
Countries of recruitment
- France
Study participating centre
Eurofin Dermscan Pharmascan
114 boulevard du 11 novembre 1918
Villeurbanne
69100
France
Villeurbanne
69100
France
Sponsor information
Kylane Laboratoires SA
Industry
Industry
c/o Samuel Gavard
Chemin du Pré-fleur 1-3
Plan Les Ouates
1228
Switzerland
| Phone | +41 (0)225889611 |
|---|---|
| s.gavard@kylane.com | |
| Website | https://www.kylane.com |
Funders
Funder type
Industry
Kylane Laboratoires SA
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Since the study will be carried out in France, the French requirements provided by the competent authority (CNIL) have to be followed. The researchers have obtained the authorization to collect data for the trial from this competent authority. The data recorded are data to characterize the trial population (birth date, gender and initials) and the assessment data performed at different timepoint. A consent form has to be obtained prior to starting the treatment. The name and surname will be anonymized by using reporting the initials on the CRFs. The data will be stored in the Trial Master File in a paper version and will not be shared with the public. These data can be checked by the competent authority upon request and will be made available within 5 business days. |
Editorial Notes
09/04/2021: Trial's existence confirmed by the French National Agency for Safety of Medicinal Products.
