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

A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

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.

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds
• Intervention / Treatment: Device: Sculptra Aesthetic 8ml; Device: Sculptra Aesthetic 5ml

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Galderma Study Site
  • California
    • Solana Beach, California, United States, 92075
      • Galderma Study Site
  • Florida
    • Bradenton, Florida, United States, 34209
      • Galderma Study Site
  • Texas
    • Austin, Texas, United States, 78746
      • Galderma Study Site
    • Spring, Texas, United States, 77388
      • Galderma Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational Study Product; Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)	Device: Sculptra Aesthetic 8ml; Treatment of nasolabial folds
ACTIVE_COMPARATOR: Reference Product; Injection with Sculptra Aesthetic reconstituted with 5ml SWFI	Device: Sculptra Aesthetic 5ml; Treatment of nasolabial folds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 as assessed by the Blinded Evaluator using WAS at X weeks	Weeks 16, 24, 32, and 40
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment	Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the subject	Weeks 16, 24, 32, 40, and 48.
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment	Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Treating Investigator	Weeks 16, 24, 32, 40 and 48
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire	Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction	Baseline and at weeks 24, 32, 40 and 48
Satisfaction With Treatment: Does the Treatment Make You Look Younger?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?	A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?	A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You do the Treatment Again?	A subject satisfaction question with responses Yes or No.	Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?	A subject satisfaction question with responses Yes or No.	Week 16, 24, 32, 40 and 48
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting	Subjects were asked to complete the following questions in the subject diary: Did you feel comfortable to return to social engagement today? (Yes or No); If yes, what was the earliest time you felt comfortable to return to social engagement? (Record date and time [using 24-hour clock])	time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 18, 2018
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): February 28, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: 43USSA1705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes