MedTrace Logo

Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

NCT03780244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-11-14

Study results available
· View outcomes & findings →

Summary

This study has been designed to evaluate the safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.

Conditions

  • Nasolabial Folds

Interventions

DEVICE

Sculptra Aesthetic 8ml

Treatment of nasolabial folds

DEVICE

Sculptra Aesthetic 5ml

Treatment of nasolabial folds

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2020-02-28
Completion
2020-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03780244 on ClinicalTrials.gov