CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 867 enrolled
Drug / intervention
injectable poly-L-lactic acid Sculptra Aestheticdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02425943
NCT02425943Phase 4Completed
CompareCT.gov

A Prospective, Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Sculptra®Aesthetic in Immuno-Competent Subjects Stratified by Fitzpatrick Skin Type I-VI)

Galderma R&D·interventional·Posted Apr 24, 2015·Updated Jul 27, 2023

In Brief

A Phase 4 clinical trial evaluating injectable poly-L-lactic acid Sculptra Aesthetic for Nasolabial Fold Contour Deficiencies and Wrinkles. Completed, enrolled 867 participants across 18 sites.

Detailed Summary

Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasolabial Fold Contour Deficiencies, Wrinkles
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 24, 2015
Enrollment StartMay 21, 2015
Primary CompletionMay 28, 2021
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 11.2 years ago

Interventions

injectable poly-L-lactic acid Sculptra Aestheticdevice