To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.
Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
Subject with intent to undergo correction of cheek augmentation or contour deficiencies
Subjects willing to have a 3-mm punch biopsy on each preauricular side
Subjects willing to maintain the current lifestyle, daily routine (e.g., diet, exercise, sleep, etc.), and a stable Body Mass Index (BMI, ± 5 kg/m2) throughout the study
Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
Single group
Sculptra®
DeviceBiostimulator
Protein Expression
Punch biopsies will be performed at the pre-auricular areas. Histology staining or immunohistochemistry will be performed on punch biopsy samples to evaluate targeted biomarkers compared to Baseline.
Subject satisfaction using self-assessment questionnaire
Subjects will be asked about their perception and satisfaction with the study treatments using a self-assessment questionnaire at visits after Baseline. The questionnaire will be a 5-point subject satisfaction questionnaire with the following responses: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree.
Click on the lead sponsor to view all of their trials.
