DRKS00029739
Completed
未知
Assessment of the Efficacy and Safety of the Use of Perfectha Deep Lidocaine in the Treatment of Nasolabial Folds, Marionette Lines and Temple Hollowing - LINAMATE
Sinclair Pharmaceuticals LtdEden HouseLakeside0 sites70 target enrollmentOctober 6, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- R23.4
- Sponsor
- Sinclair Pharmaceuticals LtdEden HouseLakeside
- Enrollment
- 70
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects between the ages of 25 and 65 years of age
- •2\. Subject seeking an aesthetic improvement of her/his face with a hyaluronic acid dermal filler product
- •3\. Any one or more of the following clinician\-assessed criteria:
- •\- moderate to severe nasolabial folds (3\-4 on the WSRS scale)
- •\- moderately deep to very long and deep marionette lines (2\-3 on the Marionette lines grading scale)
- •\- minimal to severe temporal hollowing (2\-4 on the temple hollowing scale)
- •4\. Subject having given freely and expressly his/her informed consent.
- •5\. Subject willing to have photographs of the face taken and who is willing to provide approval for the use of their study data including photographs
- •6\. Subjects must be willing and able to comply with protocol requirements, instructions, and protocol\-stated restrictions and be likely to complete the study as planned.
- •7\. Women of childbearing potential should be using a medically accepted contraceptive regimen for at least 12 weeks prior to study entry and over the entire study duration.
Exclusion Criteria
- •1\. Subjects meeting any of the following criteria will be excluded from the study: Subjects who, in the twelve months prior to their enrolment assessment had undergone:
- •\- cosmetic facial plastic surgery (other than rhinoplasty),
- •\- tissue grafting (e.g., fat injections),
- •\- tissue lifting implants (e.g., threads, barbs) or other implants,
- •\- augmentation with any permanent or semi\-permanent filler (e.g., silicone, PMMA, PLLA) or temporary filler (e.g., Ha, CaHA, PCL)
- •\- neuromodulator injections,
- •\- mesotherapy,
- •\- resurfacing (e.g., laser, radio frequency, derm\-abrasion, or chemical peel)
- •in the facial region to be treated.
- •2\. Subjects who have received any other facial aesthetic procedures that will affect the appearance in the region of the face to be treated, at any time during the study period.
Outcomes
Primary Outcomes
Not specified
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