Face skin quality improvement Skin and Connective Tissue Diseases
Conditions
Interventions
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
Sponsors
KYLYS AESTHETICS SA
Eligibility
Sex/Gender
Female
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Mauritius
Contacts
Public ContactBhavna Sewnundun
Outcome results
None listed