ISRCTN13586698
Active, Not Recruiting
N/A
Assessment of the safety and effectiveness of the use of HYDRAGEL C in the treatment of the periorbital and nasolabial fold wrinkles, cheeks and cheekbones
ouna Aesthetics0 sites75 target enrollmentAugust 21, 2023
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Subjects across groups present with moderate to severe facial aesthetic concerns, including peri-oral lines, nasolabial folds, lip volume deficits, and cheeks/cheekbones volume deficit, as gauged by various dermatological scales
- Sponsor
- ouna Aesthetics
- Enrollment
- 75
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy subject
- •2\. Sex: male or female
- •3\. Age: between 18 and 70 years
- •4\. Subject seeking an improvement of her/his face aspect with HA filler
- •\*For group 1: Subject with moderate to severe peri\-oral lines (score 3 to 5 on Bazin Upper lip scale) and lips contour requiring redefinition
- •\*For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on the WSRS scale) and/or seeking an improvement of lip volume (score 1 or 2 for superior and/or inferior lip on the Rossi scale)
- •\*For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale)
- •5\. Subject with a stable weight for the last 6 months and who agrees to keep a stable weight during the study
- •6\. Subject having given her/his free, express, and informed consent
- •7\. Subject psychologically able to understand the information related to the study, and to give their written informed consent
Exclusion Criteria
- •Population:
- •1\. Pregnant or nursing woman or planning a pregnancy during the study
- •2\. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
- •3\. Subject in a social or sanitary establishment
- •4\. Subject suspected to be non\-compliant according to the investigator’s judgment
- •5\. Subject having received a total of 6000 euros as compensation for her/his participation in clinical research in the last 12 months, including their participation in the present study
- •6\. Subject enrolled in another study or whose non\-enrollment period is not over
- •7\. Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make\-up)
- •Associated pathology:
- •8\. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety
Outcomes
Primary Outcomes
Not specified
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