Extension Study for 43USSA1705
- Conditions
- Nasolabial Folds
- Interventions
- Device: Sculptra Aesthetic 8 ml and Lidocaine
- Registration Number
- NCT04225273
- Lead Sponsor
- Galderma R&D
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705
- Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational Arm in pivotal study- 43USSA1705 Sculptra Aesthetic 8 ml and Lidocaine Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection
- Primary Outcome Measures
Name Time Method Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study) 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).
- Secondary Outcome Measures
Name Time Method 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) A responder was defined as a participant assessed as at least "Improved" (very much improved, much improved, and improved) on both sides of the face concurrently assessed using GAIS by participant. The 7-graded GAIS used by the participant to live assess the aesthetic improvement had responses as follows: (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3). 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).
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) A responder was defined as a participant assessed as at least "Improved" (very much improved, much improved, and improved) on both sides of the face concurrently assessed using GAIS by investigator. The 7-graded GAIS used by the participant to live assess the aesthetic improvement had responses as follows: (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3). 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).
FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire At Weeks 72 and 96 (assessed in the current extension study) FACE-Q™ appraisal of lines NLF scores were used to assess participant's treatment satisfaction. The sum of the participants FACE-Q™ appraisal of lines NLF scores was converted to a Rasch-transformed total score (ranged from 0 to 100) according to the FACE-Q™ manual; a higher total score indicated greater participant satisfaction. 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).
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? At Weeks 72 and 96 (assessed in the current extension study) A subject satisfaction question with responses Yes or No. 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).
Subject Satisfaction With Treatment: Would You do the Treatment Again? At Weeks 72 and 96 (assessed in the current extension study) A subject satisfaction question with responses Yes or No. 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).
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree. 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).
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? At Weeks 72 and 96 (assessed in the current extension study) A 5-point participant satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. 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).
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. 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).
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. 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).
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. 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).
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. 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).
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. 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).
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. 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).
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. 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).
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger? At Weeks 72 and 96 (assessed in the current extension study) A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. 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).
Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study) An adverse event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs of a clinical investigation in participants, whether or not related to the investigational device which included events related to the investigational product (IP) or the reference product, events related to the procedures involved and events that were anticipated as well as unanticipated. SAE: an AE resulting in death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. TEAE: any AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. 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).
Trial Locations
- Locations (1)
Galderma Study Site
🇺🇸Spring, Texas, United States