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Trial record 1 of 1 for:    43USSA1812
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Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124692
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Tracking Information
First Submitted Date  ICMJE October 10, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE November 12, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
Primary outcome [ Time Frame: Month 9 ]
Responder rate for a single regimen of Sculptra Aesthetic versus a no-treatment control in the correction of cheek wrinkles. 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
Official Title  ICMJE A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cheek Wrinkles
Intervention  ICMJE Device: Sculptra Aesthetic new dilution
Treatment of cheek wrinkles
Study Arms  ICMJE
  • No Intervention: No-treatment control group
  • Experimental: Treatment group
    Intervention: Device: Sculptra Aesthetic new dilution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alissa Calaway 8179615655 aestheticclinicaltrials@galderma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04124692
Other Study ID Numbers  ICMJE 43USSA1812
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Q-Med AB
Study Sponsor  ICMJE Q-Med AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Q-Med AB
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP