Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

Galderma

Status: Completed

Conditions: Nasolabial Folds

Treatments: Device: Sculptra Aesthetic 5ml; Device: Sculptra Aesthetic 8ml

Study type: Interventional

Funder types: Industry

Identifiers

NCT03780244

43USSA1705

Details and patient eligibility

About

This study has been designed to evaluate the 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.

Enrollment: 80 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.

Exclusion criteria

• Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Investigational Study Product

Experimental group

Description:

Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)

Treatment:

Device: Sculptra Aesthetic 8ml

Reference Product

Active Comparator group

Description:

Injection with Sculptra Aesthetic reconstituted with 5ml SWFI

Treatment:

Device: Sculptra Aesthetic 5ml