ISRCTN49836437
Active, Not Recruiting
Phase 4
Safety and effectiveness clinical evaluation of the range of Kysense® injectable medical devices in facial aesthetic treatment
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Moderate to severe peri-oral lines, moderate to severe nasolabial folds, moderate to severe cheeks/cheekbones volume deficit, chin recursion
- Sponsor
- Kylane Laboratoires SA
- Enrollment
- 68
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject seeking an improvement of her/his face aspect with HA filler
- •2\. For group 1: Subject with moderate to severe peri\-oral lines (score 3 to 5 on Bazin Upper lip scale)
- •3\. For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on WSRS scale)
- •4\. For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale)
- •5\. For group 4: Subject seeking improvement of chin retrusion
- •6\. Subject with a stable weight since the last 6 months and who agree to keep a stable weight during the study
- •7\. Subject, having given freely and expressly his/her informed consent
- •8\. Subject psychologically able to understand the study\-related information and to give a written informed consent
- •9\. Subject affiliated to a health social security system
- •10\. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks and during all the study
Exclusion Criteria
- •In terms of 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 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present study
- •6\. Subject enrolled in another study or which exclusion 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)
- •In terms of 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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