ISRCTN10640292
Active, not recruiting
未知
Safety and effectiveness clinical evaluation of injectable medical device Hydragel A1 in the skin quality improvement
ouna Aesthetics0 sites40 target enrollmentMay 2, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Patient seeking aesthetic treatment of the facial skin quality such as skin elasticity or firmness and facial skin radiance
- Sponsor
- ouna Aesthetics
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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