Extension Study for 43USSA1705

NCT04225273 | Completed Results FDA Device

• 1 other identifier: 43USSA1705ext
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

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

  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. Lower scores indicate better outcome. Effectiveness is defined as change from baseline on both sides of the face using WAS at 72 and 96 weeks after the first treatment session. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244).

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

Secondary Outcomes (16)

• Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment

  At Weeks 72 and 96 (assessed in the current extension study)

• Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment

  At Weeks 72 and 96 (assessed in the current extension study)

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

  At Weeks 72 and 96 (assessed in the current extension study)

• Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?

  At Weeks 72 and 96 (assessed in the current extension study)

• Subject Satisfaction With Treatment: Would You do the Treatment Again?

  At Weeks 72 and 96 (assessed in the current extension study)

Study Arms (1)

Sculptra Aesthetic

EXPERIMENTAL

Participants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 milliliters (mL) of sterile water for injection (SWFI) in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 \[NCT03780244\]). No investigational product was provided during this extension study.

Device: Sculptra Aesthetic, Lidocaine HCL

Interventions

Sculptra Aesthetic, Lidocaine HCL DEVICE

No intervention was administered during this extension study.

Sculptra Aesthetic

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (4)

Galderma Study Site

Scottsdale, Arizona, 85255, 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

18179615000

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: January 13, 2020
• Study Start: December 3, 2019
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)