Face skin quality 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 skin quality at 2 weeks
Sponsors
Louna Aesthetics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/02/2024: 1. Female or male 2. Any ethnicity 3. Skin phototype (according to Fitzpatrick scale) from II to V 4. Aged 30 to 60 years old 5. Seeking improvement of their skin quality 6. Have given consent for photographs for illustration purposes 7. Willing to abstain from other facial aesthetic procedures in the mid-face through the entire study duration 8. In good general and mental health in the opinion of the investigator 9. 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 10. 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 11. In the judgement of the investigator, are likely to be compliant during the study 12. Willing and capable of following the study rules and a fixed schedule 13. Willing and capable of signing an informed consent document (including the language) _____ Previous inclusion criteria: 1. Female or male 2. Any ethnicity 3. Skin phototype (according to Fitzpatrick scale) from II to V 4. Aged 18 to 45 years old 5. Seeking improvement of their skin quality 6. Have given consent for photographs for illustration purposes 7. Willing to abstain from other facial aesthetic procedures in the mid-face through the entire study duration 8. In good general and mental health in the opinion of the investigator 9. 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 10. 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 11. In the judgement of the investigator, are likely to be compliant during the study 12. Willing and capable of following the study rules and a fixed schedule 13. Willing and capable of signing an informed consent document (including the language)
Exclusion criteria
Exclusion criteria: 1. Any systemic disorder or skin disease that would in any way confound the interpretation of the study results 2. Medical/surgical/severe allergy/anaphylactic shock history that, in the opinion of the Investigator, could compromise the safety of the participant or affect the outcome of the study 3. Known risk of hypersensitivity to one of the components of the IP composition 4. Suffering from autoimmune disease 5. Cutaneous disorders, inflammation or infection (herpes, acne, etc.) at the treatment site or nearby 6. Medical history shows a sensitivity that could lead to a reaction to the treatment 7. Bleeding disorders or undergoing treatment with thrombolytics or anticoagulants 8. A tendency to form keloids, hypertrophic scars or any other healing disorders 9. 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. Deprived of their freedom by administrative or legal decision or who is under guardianship 13. Cannot be contacted by telephone in case of emergency 14. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of “HYDRAGEL A2” assessed using clinical evaluation of the global aesthetic improvement (GAIS) rated by the investigator at 2 weeks (W2) after the injection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin quality assessed by objective measurements of skin texture (roughness) at 2 and 6 weeks post-injection with Antera 3D 2. Skin quality assessed by objective measurements of: 2.1. Skin firmness/elasticity by Cutometer® 2.2. Skin hydration by Corneometer® 2.3. Skin density and thickness using Dermascan at 2 and 6 weeks after injection 3. Proportion of subjects having an improvement of the zone treated with the overall VISCOL range of devices as assessed by an independent investigator using the GAIS at 6 weeks (W6) after treatment 4. The satisfaction of the injector on the injection quality assessed using a subjective evaluation questionnaire at Day 0 5. The treatment effect of the product assessed using 2D photography at Week 2 and Week 6 6. The safety of the HYDRAGEL A2 through the incidence of signs and symptoms of skin irritation or sensitivity (using the Injection Site Reaction questionnaire) during the entire period of the study 7. The subject’s satisfaction with global aesthetic improvement (GAIS) at 2 weeks and 6 weeks after the injection 8. The effectiveness of HYDRAGEL A2 assessed using clinical evaluation of the GAIS rated by the investigator at 2 weeks and 6 weeks after the injection 9. Patient satisfaction with the treatment outcomes using a subjective evaluation questionnaire completed at 2 weeks (W2) and 6 weeks (W6) after treatment | — |
Countries
Mauritius
Contacts
Public ContactOunisha Mungur
Outcome results
None listed