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

Nasolabial Folds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780244
• Other study ID #: 43USSA1705
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: October 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• Sculptra Aesthetic 8ml
Treatment of nasolabial folds
• Sculptra Aesthetic 5ml
Treatment of nasolabial folds

Locations

Country	Name	City	State
United States	Galderma Study Site	Austin	Texas
United States	Galderma Study Site	Bradenton	Florida
United States	Galderma Study Site	Scottsdale	Arizona
United States	Galderma Study Site	Solana Beach	California
United States	Galderma Study Site	Spring	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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