Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid … (NCT05215054) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Nasolabial Folds
France59 participantsStarted 2022-03-07
Plain-language summary
The purpose of this study is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra.
Who can participate
Age range30 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject with moderate to severe nasolabial folds as determined by a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 on both folds at the pre-treatment evaluation.
* Subject wiling to abstain from other facial procedures (i.e., dermal fillers, toxin treatments, laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) during the whole study period.
* Subject, psychologically able to understand the study related information and to give a written informed consent.
* Subject having given freely and expressly his/her informed consent.
* Subject willing to have photographs of the face taken.
* Subject affiliated to a health social security system.
* Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during the whole study period.
Exclusion Criteria:
* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject with a scar, moles, pigment disorders or anything on the face which might interfere with the evaluation.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject in a social or sanitary establishment
* Subject participation to another research on human beings or who is in an exclusion period of one.
* Subject having received 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in th…
What they're measuring
1
Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment