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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 : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

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.

Condition or disease Intervention/treatment Phase
Cheek Wrinkles Device: Sculptra Aesthetic new dilution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
No Intervention: No-treatment control group
Experimental: Treatment group Device: Sculptra Aesthetic new dilution
Treatment of cheek wrinkles




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124692


Contacts
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Contact: Alissa Calaway 8179615655 aestheticclinicaltrials@galderma.com

Locations
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United States, Arizona
Galderma Research Site Not yet recruiting
Scottsdale, Arizona, United States, 85255
United States, California
Galderma Research Site Not yet recruiting
Encino, California, United States, 91436
Galderma Research Site Not yet recruiting
Redondo Beach, California, United States, 90277
Galderma Research Site
San Diego, California, United States, 92121
United States, District of Columbia
Galderma Research Site Not yet recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
Galderma Research Site Not yet recruiting
Coral Gables, Florida, United States, 33143
United States, Georgia
Galderma Research Site Not yet recruiting
Alpharetta, Georgia, United States, 30022
United States, Louisiana
Galderma Research Site Not yet recruiting
New Orleans, Louisiana, United States, 70115
United States, Maryland
Galderma Research Site Not yet recruiting
Chevy Chase, Maryland, United States, 20815
United States, New York
Galderma Research Site Not yet recruiting
New York, New York, United States, 10021
Galderma Research Site Not yet recruiting
New York, New York, United States, 10028
United States, Texas
Galderma Research Site Not yet recruiting
Dallas, Texas, United States, 75254
Galderma Research Site Not yet recruiting
Spring, Texas, United States, 77388
Sponsors and Collaborators
Q-Med AB

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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT04124692     History of Changes
Other Study ID Numbers: 43USSA1812
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs