ISRCTN37981524
Active, Not Recruiting
N/A
Safety and effectiveness clinical evaluation of injectable medical device hydragel A2 in the improvement of skin quality
ouna Aesthetics0 sites49 target enrollmentOctober 17, 2023
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Face skin quality
- Sponsor
- ouna Aesthetics
- Enrollment
- 49
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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