CompletedNot Applicable

Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

United States149 participantsStarted 2019-11-12

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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Exclusion criteria

✕. Collagen, Hyaluronic Acid - 12 months
✕. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited

What they're measuring

Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12

Timeframe: At Month 12

Trial details

NCT IDNCT04124692

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-12

Results submitted2023-10-12

View on ClinicalTrials.gov More Cheek Wrinkles trials