Safety and effectiveness clinical evaluation of injectable medical device Hydragel A1 in the skin quality improvement

Not Applicable

• Conditions: Patient seeking aesthetic treatment of the facial skin quality such as skin elasticity or firmness and facial skin radiance; Not Applicable

• Registration Number: ISRCTN10640292
• Lead Sponsor: ouna Aesthetics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-02
• Last Update Posted: 21 August 2023
• Study Completion: 2024-01-25

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>An improvement is defined as a subject with a very much improved”, much improved” or improved” score on the GAIS<br><br>