CheekNCT04595331
Open Label Extension for 43USSA1812
A study testing Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection in people with Cheek and Wrinkle, run by Galderma R&D at 13 sites in United States.
Trial summary
To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 13 sitesUnited States
- Study dates
- 12 Nov 2019to 20 Jul 2022
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject completed Month 12 of study 43USSA1812
- Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.
Who cannot join
- 1. For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Galderma Research Site
Alpharetta, Georgia, 30022
Galderma Research Site
Coral Gables, Florida, 33143
Galderma Research Site
Dallas, Texas, 75254
Galderma Research Site
Encino, California, 91436
Galderma Research Site
New Orleans, Louisiana, 70115
Galderma Research Site
New York, New York, 10021
Galderma Research Site
New York, New York, 10028
Galderma Research Site
Redondo Beach, California, 90277
Galderma Research Site
Rockville, Maryland, 20852
Galderma Research site
San Diego, California, 92121
Galderma Research Site
Scottsdale, Arizona, 85255
Galderma Research Site
Spring, Texas, 77388
Galderma Research Site
Washington D.C., District of Columbia, 20037
About this study
Official title: Open Label Extension for 43USSA1812 (A Randomized, Evaluator-blinded, No-treatment Controlled, Multi-center Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles)
To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
- Being tested
- Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra Aethestic reconsituted with 8ml Sterile Water for InjectionDevice
Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles
| Study group | Role | What they receive |
|---|---|---|
| Group A: Sculptra Aesthetic | Experimental | Subjects in this group will be treated with Sculptra aesthetic. Subjects will be followed for up to 12 months for safety and effectiveness data collection Receives: Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection |
| Group B: No Treatment | Experimental | Subjects in this group will be followed for up to 12 months with no additional treatment for long-term safety and effectiveness data collection. Receives: Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest
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 on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
Measured: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Secondary outcomes (19)
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic
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 on a scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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 rate their aesthetic improvement of the cheek wrinkles on a scale from "Very Much Improved" to "Very Much Worse" in a live assessment.
Measured: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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 rate aesthetic improvement of the cheek wrinkles on a scale from "Very Much Improved" to "Very Much Worse" in a live assessment.
Measured: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
A subject satisfaction question with responses Yes or No.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You do the Treatment Again?
A subject satisfaction question with responses Yes or No.
Measured: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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. 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.
Measured: Baseline, Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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.
Measured: From start of study drug administration up to end of the study (up to Month 24) (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start12 Nov 2019
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
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 CheekStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects originally randomized to Control Group at baseline in the pivotal 43USSA1812 study will be offered treatment with Sculptra Aesthetic in the extension study. Subjects originally randomized to Treatment Group at baseline in the pivotal 43USSA1812 study will be continued to be followed up during the extension study without further treatment.
- Masking
- None (open label)
- Enrolment
- 111 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
- NCT04595331
- Sponsor's protocol ID
- 43USSA1812ext
- Status last verified
- Jun 2025
- First submitted
- 13 Oct 2020
- Last updated
- 26 Jun 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Extension for 43USSA1812 (A Randomized, Evaluator-blinded, No-treatment Controlled, Multi-center Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles)
- ClinicalTrials.gov ID
- NCT04595331
- Acronym / sponsor ID
- 43USSA1812ext
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Posted 26 Jun 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 long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects originally randomized to Control Group at baseline in the pivotal 43USSA1812 study will be offered treatment with Sculptra Aesthetic in the extension study. Subjects originally randomized to Treatment Group at baseline in the pivotal 43USSA1812 study will be continued to be followed up during the extension study without further treatment.
| Arm | Type | Receives |
|---|---|---|
| Group A: Sculptra Aesthetic | Experimental | Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for InjectionSubjects in this group will be treated with Sculptra aesthetic. Subjects will be followed for up to 12 months for safety and effectiveness data collection |
| Group B: No Treatment | Experimental | Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for InjectionSubjects in this group will be followed for up to 12 months with no additional treatment for long-term safety and effectiveness data collection. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject completed Month 12 of study 43USSA1812
- Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.
Key exclusion criteria (1 listed)
- 1. For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.
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 Aethestic reconsituted with 8ml Sterile Water for InjectionSculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles | Device | Group A: Sculptra Aesthetic, Group B: No Treatment |
Primary outcome
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest
Time frame: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
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 on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
19 secondary outcomes
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
Time frame: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
Time frame: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You Recommend the Treatment to a Friend?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You do the Treatment Again?
Time frame: At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
Time frame: Baseline, Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From start of study drug administration up to end of the study (up to Month 24) (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection in people with Cheek and Wrinkle, run by Galderma R&D at 13 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 2 inclusion and 1 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 26 Jun 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?
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest (time frame: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)). 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 26 Jun 2025.