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Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs

NCT04830722 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-04-12

No results posted yet for this study

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

Conditions

  • Cellulite

Interventions

DEVICE

Sculptra Aesthetic

One treatment side treated with Sculptra will be compared to the other side treated with bacteriostatic water (placebo) -same volume

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • Goldman, Butterwick, Fitzpatrick and Groff

    lead OTHER

Principal Investigators

  • Sabrina Fabi, MD · Cosmetic Laser Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2022-04-01
Completion
2022-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04830722 on ClinicalTrials.gov