CompletedNot Applicable

Extension Study for 43USSA1705

United States38 participantsStarted 2019-12-03

Plain-language 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.

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705 Exclusion Criteria: * Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion * Other condition preventing the subject from entering the study in the Investigator's opinion * Participation in any interventional clinical study throughout the duration of the study

What they're measuring

Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96

Timeframe: Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study)

Trial details

NCT IDNCT04225273

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-29

Results submitted2023-02-02

View on ClinicalTrials.gov More Nasolabial Folds trials