Evaluation of the injectable medical device Hydragel A2 for skin quality improvement
- Conditions
- Face skin qualitySkin and Connective Tissue Diseases
- Registration Number
- ISRCTN37981524
- Lead Sponsor
- ouna Aesthetics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 49
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method