Nasolabial FoldsNCT04225273
Extension Study for 43USSA1705
A study testing Sculptra Aesthetic, Lidocaine HCL in people with Nasolabial Folds, run by Galderma R&D at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Sculptra Aesthetic, Lidocaine HCL
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Dec 2019to 29 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Galderma Study Site
Austin, Texas, 78746
Galderma Study Site
Bradenton, Florida, 34209
Galderma Study Site
Scottsdale, Arizona, 85255
Galderma Study Site
Spring, Texas, 77388
About this study
Official title: Open Label Extension Study for 43USSA1705 (A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds)
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.
- Conditions
- Nasolabial Folds
- Being tested
- Sculptra Aesthetic, Lidocaine HCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra Aesthetic, Lidocaine HCLDevice
No intervention was administered during this extension study.
| Study group | Role | What they receive |
|---|---|---|
| Sculptra Aesthetic | Experimental | Participants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 milliliters (mL) of sterile water for injection (SWFI) in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 [NCT03780244]). No investigational product was provided during this extension study. Receives: Device: Sculptra Aesthetic, Lidocaine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96
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).
Measured: Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study)
Secondary outcomes (16)
Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment
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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Would You do the Treatment Again?
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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
Subject 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. 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).
Measured: At Weeks 72 and 96 (assessed in the current extension study)
Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
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).
Measured: From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start3 Dec 2019
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225273
- Sponsor's protocol ID
- 43USSA1705ext
- Status last verified
- Feb 2025
- First submitted
- 4 Dec 2019
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Extension Study for 43USSA1705 (A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds)
- ClinicalTrials.gov ID
- NCT04225273
- Acronym / sponsor ID
- 43USSA1705ext
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sculptra Aesthetic | Experimental | Device: Sculptra Aesthetic, Lidocaine HCLParticipants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 milliliters (mL) of sterile water for injection (SWFI) in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 [NCT03780244]). No investigational product was provided during this extension study. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sculptra Aesthetic, Lidocaine HCLNo intervention was administered during this extension study. | Device | Sculptra Aesthetic |
Primary outcome
Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96
Time frame: 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).
16 secondary outcomes
Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Time frame: At Weeks 72 and 96 (assessed in the current extension study)
Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra Aesthetic, Lidocaine HCL in people with Nasolabial Folds, run by Galderma R&D at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 (time frame: Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.