A Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorGalderma R&D

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®

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators