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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: August 2021
- 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
- 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
- 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.
- 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
- Lead Sponsor
- Q-Med AB
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Alissa Calaway, 8179615655, firstname.lastname@example.org
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.