Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies

NCT06351358 | Completed FDA Device

• 1 other identifier: GLI.04.US.SL.036
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies.

Conditions

Photoaging; Weight Loss; Skin Laxity; Photodamaged Skin; Volume Deficiency of the Midface

Outcome Measures

Primary Outcomes (4)

• Change in skin hydration from baseline

  Corneometer (Courage + Khazaka, Germany) measurements will be taken in triplicate to assess skin hydration. The Corneometer measures in Corneometer units from 0 (no water at all) - 120 (on water).The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.

  Baseline, Week 4, Week 8, Week 16 or Week 20

• Change in skin radiance from baseline

  Glossymeter (Courage + Khazaka, Germany) measurements will be taken to assess skin radiance. The results will be expressed in Glossymeter units. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.

  Baseline, Week 4, Week 8, Week 16 or Week 20

• Change in skin elasticity from baseline

  Cutometer (Courage + Khazaka, Germany) measurements will be taken to assess skin elasticity. The Cutometer measures skin elasticity in mm penetration depth per unit of time. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.

  Baseline, Week 4, Week 8, Week 16 or Week 20

• Change in skin thickness from baseline

  DermaLab® Ultrasound (Cortex Technology, Denmark) measurements will be taken in triplicate to assess skin thickness in µm. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.

  Baseline, Week 4, Week 8, Week 16 or Week 20

Secondary Outcomes (1)

• Subject Treatment Satisfaction

  Week 4, Week 8, Week 16 or Week 20

Study Arms (1)

Sculptra and Restylane Treatment Group

EXPERIMENTAL

Subjects in the treatment group will receive the intervention with Sculptra and Restylane Lyft or Restylane Contour.

Device: Sculptra treatment; Device: Restylane Treatment

Interventions

Sculptra treatment DEVICE

Subjects will receive treatment of Sculptra at baseline. Subjects will receive a second treatment of Sculptra at Week 4 visit. At the Week 8 visit, subjects will receive an optional treatment of Sculptra.

Sculptra and Restylane Treatment Group

Restylane Treatment DEVICE

Subjects will receive treatment Restylane Lyft or Restylane Contour at baseline. Subjects will receive an optional touch-up of Restylane Lyft or Restylane Contour at Week 4 visit.

Sculptra and Restylane Treatment Group

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any Fitzpatrick skin types I-VI, with effort to include minimum n = 1 for each category per site
• Any races and ethnicities, with effort to include minimum n = 2 per site for whom identify as American Indian or Alaska Native, Eastern/Southeastern Asian, South Asians, Hispanic or Latino, Black or African American, Native Hawaiian or Other Pacific Islander, etc.
• Subject with moderate-to-severe cheek wrinkles on the GCWS
• Subject with mild-to-severe midface contour deficiencies on the MMVS
• Subject with intent to undergo correction of cheek augmentation or midface contour deficiencies.
• Subject with history of taking or currently taking GLP-1 receptor agonist medications such as semaglutide, liraglutide, etc.
• Subject with stable Body Mass Index (BMI) within 4-6 weeks before study start.
• Subject willing to maintain a stable Body Mass Index (BMI, ± 2 kg/m2) throughout the study.
• Willing to maintain the current lifestyle and daily routine (e.g., diet, exercise, sleep, etc.) throughout the study.
• Subject willing to be photographed at each visit.
• Subject willing to abstain from any other facial plastic surgical or cosmetic procedure(s) during the duration of the study.
• For female subjects of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study. Subjects must be willing to take a urine pregnancy test (UPT) prior to all treatments. (Females of non-childbearing potential, e.g., post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral ovariectomy, are not required to have a UPT.)
• Male subjects must be willing to shave prior to each study visit.
• Ability to read, understand and give consent for participation in the study.
• Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.

You may not qualify if:

• Pregnant, breastfeeding, or planning pregnancy during the course of the study.
• Current smokers or consumer of nicotine.
• History of allergy or hypersensitivity to any ingredient of the treatment products, anesthetics or lidocaine
• Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions
• Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except the lips
• History of injectable polymethylmethacrylate (PMMA) treatment
• 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 in the treatment area at any time during the study
• Presence of any disease or lesions near or on the area to be treated
• History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other non-steroidal anti-inflammatory drugs), omega 3, or vitamin E within 14 days before treatment. Omega 3 and vitamin E are acceptable only as part of a standard multivitamin formulation.
• Previous surgery, including plastic surgery, lifting threads, tissue grafting, or tissue augmentation with permanent implants, silicone, tattoo affecting the treatment area, or any procedure, at the discretion of the Investigator, would interfere with the outcome of the study.
• Other condition preventing the subject from entering the study in the Investigator's opinion
• Study site personnel, close relatives of the study site personnel (e.g., parents, children, siblings, or spouse), or employees and close relatives of employees at the Sponsor company.
• Participation in any interventional clinical study within 30 days of screening.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

Somenek + Pittman MD: Advanced Plastic Surgery

Washington D.C., District of Columbia, 20037, United States

Location

Lorenc Aesthetic Plastic Surgery Center

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Weight Loss; Cutis Laxa

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Michael Somenek, MD

  Somenek + Pittman MD: Advanced Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Paul Z Lorenc, MD

  Z. Paul Lorenc Aesthetic Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 8, 2024
• Study Start: February 19, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)