About this trial
To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sculptra®