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

NCT03780244 | Completed Results FDA Device

• 1 other identifier: 43USSA1705
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Change in Wrinkle Assessment Scale (WAS) Score

  The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session.

  48 weeks

Secondary Outcomes (17)

• Change in Wrinkle Assessment Scale (WAS) Score

  Weeks 16, 24, 32, and 40

• Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment

  Weeks 16, 24, 32, 40, and 48.

• Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment

  Weeks 16, 24, 32, 40 and 48

• FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire

  Baseline and at weeks 24, 32, 40 and 48

• Satisfaction With Treatment: Does the Treatment Make You Look Younger?

  Week 16, 24, 32, 40 and 48

Study Arms (2)

Investigational Study Product

EXPERIMENTAL

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

Device: Sculptra Aesthetic 8ml

Reference Product

ACTIVE COMPARATOR

Injection with Sculptra Aesthetic reconstituted with 5ml SWFI

Device: Sculptra Aesthetic 5ml

Interventions

Sculptra Aesthetic 8ml DEVICE

Treatment of nasolabial folds

Investigational Study Product

Sculptra Aesthetic 5ml DEVICE

Treatment of nasolabial folds

Reference Product

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.
• Collagen, Hyaluronic Acid- 12 months
• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (5)

Galderma Study Site

Scottsdale, Arizona, 85255, United States

Location

Galderma Study Site

Solana Beach, California, 92075, United States

Location

Galderma Study Site

Bradenton, Florida, 34209, United States

Location

Galderma Study Site

Austin, Texas, 78746, United States

Location

Galderma Study Site

Spring, Texas, 77388, United States

Location

Results Point of Contact

• Title: Clinical Project Manager
• Organization: QMedAB

aestheticclinicaltrials@galderma.com

817-961-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: December 18, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)