Open Label Extension for 43USSA1812

NCT04595331 | Completed Results FDA Device

• 1 other identifier: 43USSA1812ext
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 13

Brief Summary

To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.

Conditions

Cheek; Wrinkle

Outcome Measures

Primary Outcomes (1)

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

  Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.

  At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)

Secondary Outcomes (19)

• Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic

  At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)

• Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment

  At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)

• Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment

  At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)

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

  At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)

• Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?

  At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)

Study Arms (2)

Group A: Sculptra Aesthetic

EXPERIMENTAL

Subjects in this group will be treated with Sculptra aesthetic. Subjects will be followed for up to 12 months for safety and effectiveness data collection

Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection

Group B: No Treatment

EXPERIMENTAL

Subjects in this group will be followed for up to 12 months with no additional treatment for long-term safety and effectiveness data collection.

Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection

Interventions

Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection DEVICE

Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles

Group A: Sculptra Aesthetic; Group B: No Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject completed Month 12 of study 43USSA1812
• Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (13)

Galderma Research Site

Scottsdale, Arizona, 85255, United States

Location

Galderma Research Site

Encino, California, 91436, United States

Location

Galderma Research Site

Redondo Beach, California, 90277, United States

Location

Galderma Research site

San Diego, California, 92121, United States

Location

Galderma Research Site

Washington D.C., District of Columbia, 20037, United States

Location

Galderma Research Site

Coral Gables, Florida, 33143, United States

Location

Galderma Research Site

Alpharetta, Georgia, 30022, United States

Location

Galderma Research Site

New Orleans, Louisiana, 70115, United States

Location

Galderma Research Site

Rockville, Maryland, 20852, United States

Location

Galderma Research Site

New York, New York, 10021, United States

Location

Galderma Research Site

New York, New York, 10028, United States

Location

Galderma Research Site

Dallas, Texas, 75254, United States

Location

Galderma Research Site

Spring, Texas, 77388, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Head of Development
• Organization: Q-Med AB

reception.seupp@galderma.com

+46184749000

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects originally randomized to Control Group at baseline in the pivotal 43USSA1812 study will be offered treatment with Sculptra Aesthetic in the extension study. Subjects originally randomized to Treatment Group at baseline in the pivotal 43USSA1812 study will be continued to be followed up during the extension study without further treatment.

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: November 12, 2019
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)