Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs
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ClinicalTrials.gov Identifier: NCT04830722 |
Recruitment Status : Unknown
Verified April 2021 by Leslie Laser Aguilar, Goldman, Butterwick, Fitzpatrick and Groff.
Recruitment status was: Recruiting
First Posted : April 5, 2021
Last Update Posted : April 12, 2021
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Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Collaborator:
Galderma R&D
Information provided by (Responsible Party):
Leslie Laser Aguilar, Goldman, Butterwick, Fitzpatrick and Groff
Tracking Information | |||||||
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First Submitted Date ICMJE | March 29, 2021 | ||||||
First Posted Date ICMJE | April 5, 2021 | ||||||
Last Update Posted Date | April 12, 2021 | ||||||
Actual Study Start Date ICMJE | April 9, 2021 | ||||||
Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
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 | Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs | ||||||
Official Title ICMJE | A Randomized Single Center, Double Blinded, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs | ||||||
Brief Summary | clinical trial is to assess the safety, efficacy and patient satisfaction associated with the treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic | ||||||
Detailed Description | Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic. Up to four (4) vials of Sculptra Aesthetic, diluted at 16 mL, will be used per treatment session. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic. Masking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE | Cellulite | ||||||
Intervention ICMJE | Device: Sculptra Aesthetic
One treatment side treated with Sculptra will be compared to the other side treated with bacteriostatic water (placebo) -same volume
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
20 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 1, 2022 | ||||||
Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 60 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04830722 | ||||||
Other Study ID Numbers ICMJE | Sculptra-Aesthetic-2021 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Leslie Laser Aguilar, Goldman, Butterwick, Fitzpatrick and Groff | ||||||
Original Responsible Party | Leslie Aguilar, Goldman, Butterwick, Fitzpatrick and Groff, Regulatory Affairs Administrator | ||||||
Current Study Sponsor ICMJE | Goldman, Butterwick, Fitzpatrick and Groff | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Galderma R&D | ||||||
Investigators ICMJE |
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PRS Account | Goldman, Butterwick, Fitzpatrick and Groff | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |