Patient seeking aesthetic treatment of the facial skin quality such as skin elasticity or firmness and facial skin radiance Other
Conditions
Interventions
Hydragel A1 device is a sterile, transparent and resorbing gel of hyaluronic acid of biofermentative origin. Tranexamic acid, a substance widely used in the cosmetic industry, is incorporated into the
Sponsors
Louna Aesthetics
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female and male subjects 2.Fitzpatrick skin of the face from III to V 3. Aged between 18 to 45 years old 4. Subjects seeking an improvement in their skin brightness 5. Subjects seeking improvement of their skin quality 6. Subjects of any phototype and ethnicity 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 given their free, informed and expressed written consent 11. 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 12. 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 13. Subjects who, in the judgement of the investigator, are likely to be compliant during the study 14. Subjects willing and capable of following the study rules and a fixed schedule 15. 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 the 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 a 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects having an improvement of the zone treated measured using the Global Aesthetic Improvement Scale (GAIS) as assessed by the investigator, 4 weeks (W4) after the first injection. An improvement is defined as a subject with a “very much improved”, “much improved” or “improved” score on the GAIS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The safety and tolerance of Hydragel A1 measured by assessing the incidence of signs and symptoms of skin irritation or sensitivity using an Injection Site Reaction questionnaire during the entire period of the study. For this purpose, AEs and SAEs will also be monitored. 2. The effectiveness of Hydragel A1 at improving skin quality by objective measurements of skin roughness/texture using the Antera 3D camera for skin analysis at 4 and 10 weeks after the first injection. The following effectiveness parameters of Hydragel A1 will be evaluated: 2.1. Skin firmness/elasticity by Cutometer® 2.2. Skin hydration by Corneometer® 2.3. Skin density & thickness through Dermascan 2.4. Skin brightness using Chromameter 3. The effectiveness of Hydragel A1 10 weeks after the 1st injection using clinical evaluation of the GAIS rated the investigator. 4. The subject’s satisfaction on global aesthetic improvement (GAIS) 2 weeks, 4 weeks and 10 weeks after the 1st injection. 5. The injection satisfaction on the injection quality using subjective evaluation questionnaire. Additionally, standardized photography will be made for the purpose of efficacy illustration, subsequently image-analyzed and scored by independent assessors for various features including Mid-face volume deficit. | — |
Countries
France, Mauritius
Outcome results
None listed