A study to test the safety and effectiveness of KYLIPS cheek filler for restoring volume in the midface area
| ISRCTN | ISRCTN77263525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77263525 |
- Submission date
- 15/05/2025
- Registration date
- 23/05/2025
- Last edited
- 16/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
KYLIPS medical device is classified as medical device and intended purpose of KYLIPS device is to improve facial skin quality attributes such as volume restoration, skin elasticity or firmness and skin texture. KYLIPS is intended to be used by healthcare professionals in accordance to local regulations for this kind of treatment. the purpose of this investigational clinical study is to confirm the clinical effectiveness and safety of the KYLIPS device in the intended use. The follow-up visits will be performed after 1 month, 6 months and 12 months.
Who can participate?
KYLIPS devices are intended to be administered to be used in healthy subjects aged between 30 and 60 years and who are seeking for aesthetic treatment of facial aging with the improvement of facial skin quality such as volume restoration, skin elasticity or firmness and skin texture.
What does the study involve?
The study duration is 12 months. Subjects will undergo a screening visit followed by a visit at D-3-D0 whereby several parameters will be measured for volume restoration, skin firmness/elasticity and texture (roughness).
At Baseline visit (D0), “KYLIPS” will be injected on both cheeks and a subjective evaluation will be done by the injector. After 4 weeks (W4), 26 weeks (W26), and 52 weeks (W52) skin parameters measured for volume restoration, skin firmness/elasticity and texture.
What are the possible benefits and risks of participating?
Injection of hyaluronic acid is generally well-tolerated, and most side effects are mild in intensity and transient in nature. They are related to the injection procedure rather than the implant itself.
The most frequent adverse events associated with dermal fillers injections include bruising, redness, swelling, pain, tenderness, itching, rash, erythema (FDA, 2015; NHS, 2016).
Less common side effects are raised bumps or lumps in or under the skin (nodules or granulomas) that may need to be surgically removed, infection, open or draining wounds, a sore at the injection site, allergic reaction, necrosis (tissue death) (FDA, 2015).
The following rare side effects have also been reported (FDA, 2015 / FDA, 2021): severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance, migration/movement of filler material from the site of injection, leakage or rupture of the filler material at the injection site (not relevant in the case of a HA and PN filler) or through the skin (which may result from tissue reaction or infection), the formation of permanent hard nodules, vision abnormalities, including blindness, stroke (due to cerebral ischemia or cerebral hemorrhage), injury to the blood supply, damage to the skin or the lips.
The observed complications with dermal fillers can be classified by onset of adverse events:
Early reactions (up to 24h after procedure to 4 weeks, according to Urdiales- Galvez et al. (2018))
• Vascular adverse event/soft-tissue necrosis
• Inflammatory reactions (acute/chronic)
• Infection
• Allergic reactions/hypersensitivity
• Injection-related events
• Pain
• Ecchymosis
• Erythema
• Bruising
• Bleeding
• Inappropriate/superficial placement
• Distant spread
Late reactions (more than 4 weeks, according to Urdiales-Galvez et al. (2018))
• Inflammatory reactions (acute/chronic)
• Infection
• Granuloma (typically chronic)
• Differential diagnosis
• Nodules
• Dyspigmentation
• Displacement of hyaluronic acid filler material
Where is the study run from?
KYLYS AESTHETICS SA (Switzerland)
When is the study starting and how long is it expected to run for?
Aug 2025 to Nov 2026
Who is funding the study?
KYLYS AESTHETICS SA (Switzerland)
Who is the main contact?
Dr Ounisha Mungur, o.mungur@cidp-cro.com
Bhavna SEWNUNDUN, b.sewnundun@cidp-cro.com
Contact information
Public
BioPark Mauritius, SOCOTA Phoenicia
Sayed Hossen Road
Phoenix
73408
Mauritius
| Phone | +230 4012600 |
|---|---|
| b.sewnundun@cidp-cro.com |
Scientific, Principal Investigator
BioPark Mauritius, SOCOTA Phoenicia
Sayed Hossen Road
Phoenix
73408
Mauritius
| Phone | +230 4012600 |
|---|---|
| g.petkar@cidp-cro.com |
Study information
| Study design | Prospective open interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A class III medical device study to evaluate the safety and effectiveness of KYLIPS injectable cheek filler in adults with midface volume deficit |
| Study objectives | The null hypothesis states that less than 40% of subjects are responders with GAIS. It is assumed that under the alternative hypothesis 65% of subjects are responders. Using a two-sided exact one-sample binomial test, 55 subjects are required to show with a power of 90% a significant result (alpha = 5%). |
| Ethics approval(s) |
Approved 11/06/2025, Clinical Research Regulatory Council (Atchia Building, Suffren Street, Port-Louis, 11405, Mauritius; +230 (0)59439503; crrc@govmu.org), ref: 2324CMCL027 |
| Health condition(s) or problem(s) studied | Face skin quality improvement |
| Intervention | This study will be conducted as a prospective and open study to evaluate the effectiveness of the Medical Device on the improvement of skin quality by objective measurements of facial skin quality at 4 weeks (W4), 26 weeks (W26) and 52 weeks (W52) post injection. Subjects will undergo a screening visit followed by a visit at D-3-D0 whereby several parameters will be measured for volume restoration, skin firmness/elasticity and texture (roughness). At Baseline visit (D0), “KYLIPS” will be injected on both cheeks and a subjective evaluation will be done by the injector. After 4 weeks (W4), 26 weeks (W26), and 52 weeks (W52) skin parameters measured for volume restoration, skin firmness/elasticity and texture. KYLIPS medical device is classified as a class III (rule 8, Chapter III of the Regulation (EU) 2017/745 and rule 18) and class D - rule 8 as per the Guidance of Medical Devices Classification – MDS-G42 – Saudi FDA – v1.0/27-11-2019. KYLIPS device is a sterile, and resorbing gel of hyaluronic acid of bio fermentative origin. KYLIPS device is a sterile, transparent and resorbing gel of hyaluronic acid of biofermentative origin. KYLIPS devices act by providing aesthetic benefits to patients who are seeking aesthetic treatment of deep skin depressions and lips enhancement at the level of the face. This medical device contains hyaluronic acid cross-linked with poly(N-isopropylacrylamide) that creates a volume in the skin tissues that corrects facial anatomy and treats the facial aging. Each device has the following characteristics: • Injectable resorbable gel (non-permanent gel), • Based on hyaluronic acid substituted with poly (N isopropylacrylamide) • Sterile and single use, • Packaged in 1 mL plastic syringes with integrated luer-lock, in a volume of 1 mL, • Accompanied by a single use sterile needle CE-marked compatible with luer-lock system, • Equipped with a suitable backstop and plunger rod on the syringe, • Presented in a secondary packaging that protects the integrity of each syringe, • Stored either in ambient or refrigerated conditions for up to 36 months. KYLIPS devices have the following properties: Composition: Bioconjugate hyaluronic acid : 14 mg/mL Phosphate buffer saline: q.s. 1 mL Form: Injectable sterile gels in syringe Mode of administration: KYLIPS is intended to be administrated via deep dermis injection or subdermally by an authorized health professional Primary Packaging: Syringe of 1 mL Needle: 30G ½ (inch) Secondary Packaging: Presented in a secondary packaging that protects the integrity of each syringe and equipped with a suitable backstop and plunger rod on the syringe Storage: Between 2 and 25°C away from sunlight Up to 3 years of expiry date The raw materials and components which compose KYLIPS products are compliant with the European Pharmacopoeia when monographs exist and/or applicable normative standards. The production of KYLIPS is subcontracted to a contract manufacturer which is specialised in the manufacturing of medical devices and pharmaceutical products. Each box (= secondary packaging) of KYLIPS device contains two pre-filled syringes of KYLIPS, 4 needles and set of implant cards. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | KYLIPS |
| Primary outcome measure | Effectiveness of injectable cheek filler “KYLIPS” 4 weeks (W4) after the injection using clinical evaluation of the global aesthetic improvement (GAIS) rated by the investigator. |
| Secondary outcome measures | 1. Evaluate the improvement of mid-face volume deficit by clinical scoring at D-3 and D0, D0, 4 weeks (W4), 26 weeks (W26) and 52 weeks (W52) after injection by investigator using Allergan Cheek volume scale. 2. Evaluate the effectiveness of “KYLIPS” on the improvement of skin quality by objective measurements of skin texture (roughness) at 4 weeks (W4), 26 weeks (W26) and 52 weeks (W52) post injection with Antera 3D. 3. Evaluate the effectiveness of “KYLIPS” on the improvement of skin quality by objective measurements of skin firmness/elasticity by Cutometer® on 4 weeks (W4), 26 weeks (W26) and 52 weeks (W52) after injection. 4. The effectiveness of “KYLIPS” 4 weeks (W4) after the injection using clinical evaluation of the GAIS rated by the subject. 5. The effectiveness of “KYLIPS” 4 weeks (W4), 26 weeks (W26) and 52 weeks (W52) after the injection using clinical evaluation of the GAIS rated by the subject. 6. To evaluate the satisfaction of the injector on the injection quality using subjective evaluation questionnaire. 7. To illustrate the treatment effect of the product through 2D photography and ¾ angle. 8. To assess the safety of the “KYLIPS” through the incidence of signs and symptoms of skin irritation or sensitivity (using Injection Site Reaction questionnaire from both subject and investigator) during the entire period of the study. 9. Patient satisfaction on the treatment outcomes using a subjective evaluation questionnaire completed at 4 weeks (W4), 26 weeks (W26) and 52 weeks (W52) post injection. 10. Additionally, standardized photography will be made for the purpose of efficacy illustration, subsequently image-analysed and scored by independent assessors for various features including Mid face volume deficit. |
| Overall study start date | 15/05/2025 |
| Completion date | 23/11/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 60 Years |
| Sex | Female |
| Target number of participants | 55 |
| Key inclusion criteria | 1. Female subjects 2. Aged between 30 to 60 years old 3. Subjects of any phototype 4. 50% Caucasian panel 5. Subject seeking increase in midface volume 6. Subjects seeking improvement of their skin quality 7. Subjects who have given their consent for photographs for illustration purposes 8. Subjects willing to abstain from other facial aesthetic procedures in the mid-face through the entire study duration 9. Subjects in good general and mental health in the opinion of the investigator 10. Subjects who have the ability to read and fully understand the aims of the study and its conduct and have given their free, informed and expressed written consent 11. Subjects agreeing to cooperate, in full awareness of the study objectives, the necessity and the duration of the follow-up controls at the trial site to ensure perfect adherence to protocol 12. Subjects who, in the judgement of the investigator, are likely to be compliant during the study 13. Subjects willing and capable of following the study rules and a fixed schedule 14. Subjects willing and capable to sign an informed consent document (including the language) |
| Key exclusion criteria | 1. Subject with any systemic disorder or skin disease that would in any way confound interpretation of the study results 2. Subjects with medical/surgical/severe allergy/anaphylactic shock history that, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study 3. Subjects having known risk of hypersensitivity to one of the components of the composition 4. Subjects suffering from autoimmune disease 5. Subjects having cutaneous disorders, inflammation or infection (herpes, acne, etc.) at the treatment site or nearby 6. Subjects for whom medical history shows a sensitivity that could lead to a reaction to the treatment 7. Subjects with bleeding disorders or in subjects who are undergoing treatment with thrombolytics or anticoagulants 8. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders 9. Subjects who are currently following a skin treatment 10. Pregnant or breastfeeding women or those considering a pregnancy during the study 11. Female subjects of childbearing potential with a positive urine pregnancy test (UPT) at D-3–D0 12. Subject who has been deprived of their freedom by administrative or legal decision or who is under guardianship 13. Subject who cannot be contacted by telephone in case of emergency 14. Subject in an exclusion period or participating in another biomedical research study (self-reported) 15. Intellectual/mental inability to follow study instructions (if suspected) or incapacitation 16. Prior adverse reaction to hyaluronic acid treatment (injectable or over-the-counter topical) 17. Connective tissue disorder 18. Active infection in treatment area 19. Active severe inflammatory disease in treatment area such as atopic dermatitis, psoriasis 20. Treatment with toxin or filler in lower face below the orbital rim within the past 6 months |
| Date of first enrolment | 10/07/2025 |
| Date of final enrolment | 16/10/2025 |
Locations
Countries of recruitment
- Mauritius
Study participating centre
Phoenix
73408
Mauritius
Sponsor information
Industry
Route de la Galaise 34
c/o Fondation Genevoise pour l'Innovation Technologique, FONGIT, 1228 Plan-les-Ouates
FongIt
1228
Switzerland
| Phone | +41 79 735 08 74 |
|---|---|
| bryan.porcello@kylys.com | |
| Website | https://kylysaesthetics.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
16/07/2025: Ethics approval details added.
22/05/2025: Study's existence confirmed by KYLYS AESTHETICS SA.
