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Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

NCT04124692 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2023-11-18

Study results available
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Summary

The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.

Conditions

  • Cheek Wrinkles

Interventions

DEVICE

Sculptra Aesthetic new dilution

Treatment of cheek wrinkles

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2021-08-12
Completion
2021-08-12
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 NCT04124692 on ClinicalTrials.gov