Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

Galderma

Status: Completed

Conditions: Cheek Wrinkles

Treatments: Device: Sculptra Aesthetic new dilution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04124692

43USSA1812

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.

Exclusion criteria

• Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.

• Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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149 participants in 2 patient groups

Control Group: No-treatment

No Intervention group

Description:

Participants will receive no treatment during the study.

Treatment Group: Sculptra Aesthetic

Experimental group

Description:

Participants will be injected with Sculptra Aesthetic by Treating Investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions)

Treatment:

Device: Sculptra Aesthetic new dilution