Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

Overview

The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.

Full Title of Study: “A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2021

Interventions

  • Device: Sculptra Aesthetic new dilution
    • Treatment of cheek wrinkles

Arms, Groups and Cohorts

  • No Intervention: No-treatment control group
  • Experimental: Treatment group

Clinical Trial Outcome Measures

Primary Measures

  • Responder rate for a single regimen of Sculptra Aesthetic versus a no-treatment control in the correction of cheek wrinkles.
    • Time Frame: Month 9
    • A responder is defined as a participant with at least 1 grade improvement from baseline on both sides of the face concurrently, on the Galderma Cheek Wrinkles Scale (GCWS) ranging from 0 (none) to 4 (very severe).

Participating in This Clinical Trial

Inclusion Criteria

  • Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.

Exclusion Criteria

  • Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
  • Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:

1. Collagen, Hyaluronic Acid – 12 months

2. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Q-Med AB
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Alissa Calaway, 8179615655, aestheticclinicaltrials@galderma.com

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