Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

Cheek Wrinkles Clinical Trial

Official title:

A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124692
• Other study ID #: 43USSA1812
• Status: Completed
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: August 12, 2021

Study information

• Verified date: November 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.

Exclusion Criteria:

• Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.

• Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:

1. Collagen, Hyaluronic Acid - 12 months

2. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited

Related Conditions & MeSH terms

• Cheek Wrinkles

Intervention

Device:
• Sculptra Aesthetic new dilution
Treatment of cheek wrinkles

Locations

Country	Name	City	State
United States	Galderma Research Site	Alpharetta	Georgia
United States	Galderma Research Site	Coral Gables	Florida
United States	Galderma Research Site	Dallas	Texas
United States	Galderma Research Site	Encino	California
United States	Galderma Research Site	New Orleans	Louisiana
United States	Galderma Research Site	New York	New York
United States	Galderma Research Site	New York	New York
United States	Galderma Research Site	Redondo Beach	California
United States	Galderma Research Site	Rockville	Maryland
United States	Galderma Research Site	San Diego	California
United States	Galderma Research Site	Scottsdale	Arizona
United States	Galderma Research Site	Spring	Texas
United States	Galderma Research Site	Washington	District of Columbia

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	Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12	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: 0 (none [no lines or wrinkles]), 1 (mild [only few superficial lines]), 2 (moderate [many superficial lines or a few shallow wrinkles]), 3 (severe [many shallow wrinkles or a few moderate depth wrinkles]) and 4 (very severe [many moderate wrinkles or at least one depth wrinkle with or without redundant folds]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.	At Month 12
Secondary	Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9	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: 0 (none [no lines or wrinkles]), 1 (mild [only few superficial lines]), 2 (moderate [many superficial lines or a few shallow wrinkles]), 3 (severe [many shallow wrinkles or a few moderate depth wrinkles]) and 4 (very severe [many moderate wrinkles or at least one depth wrinkle with or without redundant folds]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.	At Months 7 and 9
Secondary	Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12	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: 0 (none [no lines or wrinkles]), 1 (mild [only few superficial lines]), 2 (moderate [many superficial lines or a few shallow wrinkles]), 3 (severe [many shallow wrinkles or a few moderate depth wrinkles]) and 4 (very severe [many moderate wrinkles or at least one depth wrinkle with or without redundant folds]). Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.	At Months 7, 9, and 12
Secondary	Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment	Improvement rate based on the Independent Photographic Reviewer's assessment using random pairings of baseline and Month 12 photographs was done.; An improved subject is defined as a subject for whom the Independent Photographic Reviewer identified the month 12 photograph in the pair as post-treatment.	At Month 12
Secondary	Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment	GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.	At Months 7, 9, and 12
Secondary	Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment	GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Make You Look Younger?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	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: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
Secondary	Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?	A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.	At Months 7, 9, and 12
Secondary	Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?	A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.	At Months 7, 9, and 12
Secondary	Subject Satisfaction: Would You Recommend the Treatment to a Friend?	A subject satisfaction question with responses Yes or No.	At Month 12
Secondary	Subject Satisfaction: Would You do the Treatment Again?	A subject satisfaction question with responses Yes or No.	At Month 12
Secondary	Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores	The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement.	Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important medical event. TEAEs included both serious and non-serious TEAEs.	From start of study drug administration up to end of the study (up to Month 12)