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Extension Study for 43USSA1705

NCT04225273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-03-12

Study results available
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Summary

To evaluate the long-term 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, Lidocaine HCL

No intervention was administered during this extension study.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2021-01-29
Completion
2021-01-29
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 NCT04225273 on ClinicalTrials.gov