Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies
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
Study Start (Actual) 2024-02-19
Primary Completion (Estimated) 2024-10-31
Study Completion (Estimated) 2024-10-31
Enrollment (Estimated) 40
Study Type INTERVENTIONAL
Phase NA
Locations:
📍 Washington, District of Columbia, United States
📍 New York, New York, United States

Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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.

    Exclusion Criteria:

    • * 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.
    • * Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion
    • * 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.
Ages Eligible for Study: 22 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2024-03-20
  • First Submitted that Met QC Criteria2024-04-01
  • First Posted2024-04-08

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-04-09
  • Last Update Posted2024-04-11
  • Last Verified2024-03