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NCT04595331 · ClinicalTrials.gov registry record · NA

Open Label Extension for 43USSA1812

A NA study of Wrinkle and Cheek, sponsored by Galderma R&D.

Completed
Registry status
NA
Development phase
111
Enrollment target
13
Study locations

NCT04595331 is a NA study of Wrinkle and Cheek that has completed, run by Galderma R&D. The registered enrollment target is 111 participants, roughly in line with the 116-participant average among 25 other Wrinkle trials with a reported enrollment target. The trial reports 13 study locations across 9 states.

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The verdict

NCT04595331, a NA study of Wrinkle and Cheek, has completed, sponsored by Galderma R&D.

COMPLETED
Registry status
NA
Development phase
111 participants
Enrollment target
13
Study locations

Study Summary

To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.

Conditions Studied

Interventions

  • DEVICE Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection

Study Locations (13)

California

  • Galderma Research Site - Encino
  • Galderma Research Site - Redondo Beach
  • Galderma Research site - San Diego

New York

  • Galderma Research Site - New York
  • Galderma Research Site - New York

Texas

  • Galderma Research Site - Dallas
  • Galderma Research Site - Spring

Arizona

  • Galderma Research Site - Scottsdale

District of Columbia

  • Galderma Research Site - Washington D.C.

Florida

  • Galderma Research Site - Coral Gables

Georgia

  • Galderma Research Site - Alpharetta

Louisiana

  • Galderma Research Site - New Orleans

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2019-11-12
Est. Completion 2022-07-20
Phase NA

Sponsor

Galderma R&D

158 total trials

What the Registry Record Tells You About NCT04595331

The ClinicalTrials.gov registry entry for NCT04595331 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 116-participant average among 25 other Wrinkle trials with a reported enrollment target. The listed sponsor is Galderma R&D, which has 158 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Wrinkle appearing as the primary indexed condition, and to 1 intervention - of which Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection is the first listed.

NCT04595331 reports 13 study locations spanning 9 distinct geographic areas - top geographies include California, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT04595331 about?

NCT04595331 is a clinical study titled "Open Label Extension for 43USSA1812". To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.

What is the current status of trial NCT04595331?

This trial is currently completed. It is a NA study. The enrollment target is 111 participants. The study started on 2019-11-12. Estimated completion is 2022-07-20.

What conditions does trial NCT04595331 study?

This clinical trial studies the following conditions: Wrinkle, Cheek.

What interventions are being tested in trial NCT04595331?

The interventions under investigation include: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection (DEVICE).

Who is sponsoring clinical trial NCT04595331?

This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04595331 being conducted?

This trial has 13 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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