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Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell

NCT05269654 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-03-08

No results posted yet for this study

Summary

To assess the safety, efficacy and subject satisfaction associated with volumization of the hip dell with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX).

Conditions

  • Skin Laxity

Interventions

DEVICE

injectable poly-L-lactic acid

Injectable biostimulant for volume loss

OTHER

Normal Saline

Sham Comparator

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • Goldman, Butterwick, Fitzpatrick and Groff

    lead OTHER

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
2022-03-04
Primary Completion
2023-12-31
Completion
2024-03-01
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 NCT05269654 on ClinicalTrials.gov