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Histology Study of Biostimulatory Activity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic)

NCT04957446 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-08-11

No results posted yet for this study

Summary

The study device, Sculptra, is an injectable implant formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that subjects' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow". Based upon the study doctor's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease in skin redness and pore size. In this study we evaluate the existence of histopathological (microscopic examination of tissue) evidence that can explain the observed improvement of skin quality after poly-L-lactic acid injections. Specifically, we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to restoring skin health and epidermal thickness.

Conditions

  • Nasolabial Fold
  • Facial Wrinkles

Interventions

DEVICE

Sculptra Aesthetic

Injectable implant containing microparticles of poly-L-lactic acid (PLLA)

OTHER

Placebo

Saline solution

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • Sadick Research Group

    lead OTHER

Principal Investigators

  • Neil Sadick, M.D. · Sadick Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2022-07-01
Completion
2022-09-01
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 NCT04957446 on ClinicalTrials.gov