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

Official title

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

Overview

To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.

Detailed description

This is a randomized, prospective study. This study will enroll approximately 40 subjects across two sites. All subjects have moderate-to-severe cheek wrinkles on both cheeks.

Eligible subjects will first receive punch biopsy on one pre-auricular side according to a pre-determined randomization, followed by a first Sculptra treatment on both cheeks starting at the pre-auricular areas first at Baseline visit. Subjects will receive second Sculptra treatment at Week 4, and an optional third treatment at Week 8. At 12 weeks since last Sculptra treatment, half of the subjects will receive a second punch biopsy on the other pre-auricular side (per randomization). Subjects will have a follow up visit at 24 weeks since last Sculptra treatment. At 36 weeks since last Sculptra treatment, the remaining half will receive a second punch biopsy on the other pre-auricular side (per randomization).

Interventions

• Device Sculptra®
  Biostimulator

Primary outcome measures

• Protein Expression [Time frame: 12 weeks, 24 weeks, and 36 weeks after Baseline]

Secondary outcome measures (1)

• Subject satisfaction using self-assessment questionnaire [Time frame: 12 weeks, 24 weeks, and 36 weeks since final Sculptra treatment]

Eligibility criteria

Inclusion criteria

• 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
• Ability of giving consent for participation in the study.
• Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.

Exclusion criteria

• 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.
• Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Miami Dermatology & Laser Institute — Miami
• Day Dermatology & Aesthetics — New York

Identifiers

NCT: NCT07342400 · GLI.04.US.SL.049

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗