Nasolabial Fold Contour DeficienciesPhase 4NCT02425943
Sculptra Aesthetic Post-Approval Study
A Phase 4 study testing injectable poly-L-lactic acid Sculptra Aesthetic in people with Nasolabial Fold Contour Deficiencies and Wrinkles, run by Galderma R&D at 18 sites in United States.
Trial summary
Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasolabial Fold Contour Deficiencies, Wrinkles
- What is being tested?
- injectable poly-L-lactic acid Sculptra Aesthetic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 867 participants
- Where
- 18 sitesUnited States
- Study dates
- 21 May 2015to 28 May 2021
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects seeking correction of shallow to deep NLF contour deficiencies.
Who cannot join
- Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds.
- Subjects that are less than 18 or greater than 75 years of age.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Galderma Study Site
Austin, Texas, 78746
Galderma Study Site
Aventura, Florida, 33180
Galderma Study Site
Birmingham, Alabama, 32405
Galderma Study Site
Boca Raton, Florida, 33486
Galderma Study Site
Buffalo Grove, Illinois, 60089
Galderma Study Site
Coral Gables, Florida, 33146
Galderma Study Site
Encino, California, 91436
Galderma Study Site
Hackensack, New Jersey, 07601
Galderma Study Site
Hermosa Beach, California, 90254
Galderma Study Site
Houston, Texas, 77056
Galderma Study Site
Miami, Florida, 33137
Galderma Study Site
Nashville, Tennessee, 37215
Galderma Study Site
New York, New York, 10016
Galderma Study Site
Plano, Texas, 75093
Galderma Study Site
San Diego, California, 92121
Galderma Study Site
Solana Beach, California, 92075
Galderma Study Site
Spokane, Washington, 99202
Galderma Study Site
White Plains, New York, 10604
About this study
Official title: A Prospective, Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Sculptra®Aesthetic in Immuno-Competent Subjects Stratified by Fitzpatrick Skin Type I-VI)
Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.
- Conditions
- Nasolabial Fold Contour Deficiencies, Wrinkles
- Being tested
- injectable poly-L-lactic acid Sculptra Aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable poly-L-lactic acid Sculptra AestheticDevice
Also called Sculptra Aesthetic
| Study group | Role | What they receive |
|---|---|---|
| Sculptra Aesthetic | Experimental | Not described Receives: Device: injectable poly-L-lactic acid Sculptra Aesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Any Injection Site Nodule and/or Papule
Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to [>=] 0.5 (cm); papule less than [<] 0.5 cm). Percentage of participants with any injection site nodule and/or papule were reported.
Measured: Up to 5 years
Percentage of Participants With Any Adverse Events of Interest (AEIs)
AEIs means: "serious or non-serious adverse event that is one of scientific and medical concern specific to the sponsor's product for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Examples of AEIs were hypertrophic scarring, keloid formation, hypersensitivity reactions, skin necrosis, unexpected change in wrinkle contour, granuloma, changes in the skin pigmentation at the site of injection compared to adjacent. Percentage of participants with any AEIs (other than injection site nodule and/or papule) were reported.
Measured: Up to 5 years
Secondary outcomes (6)
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
NLF severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.
Measured: Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. The physician assessed the left side and the right side of the participant's face using the 5-point scale where scoring of 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 investigator at defined timepoints. Higher scores mean a worse outcome.
Measured: Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
Marionette Lines severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.
Measured: Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
Chin Crease severity was assessed by the evaluating investigator from WAS. WAS was based on a 6-point assessment grade where 0=no wrinkles; 1=just perceptible wrinkle; 2=shallow wrinkle; 3=moderately deep wrinkle; 4=deep wrinkle, well-defined edges; 5=very deep wrinkle, redundant fold. The calculations for average WAS was based on data corresponding to only the nasolabial folds (NLFs) treated at the initial visit, that is., only WAS scores for treated sides was considered. The average WAS was calculated from the individual left and right NLFs scores. If the WAS was only available for one side, then the average WAS was the score for the one side.
Measured: Baseline, Months 6,13 and Years 2,3 4,5
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale
Efficacy was assessed by overall facial improvement assessed live by the Investigator assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a subjective test. The investigator independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement.
Measured: At 6,13 months, 2, 3, 4 and 5 years
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale
Efficacy was assessed by overall facial improvement assessed live by the participants assessment of facial appearance including the GAIS. The GAIS is a subjective test. The participant independently describes the degree of improvement in facial appearance. Possible scores were + 3: Much improved, +2: Moderately improved, +1: Slightly improved, 0: No change, -1: Slightly worse, -2: Moderately worse, -3: Much worse. 'Not Improved' included participants with scores of 0, -1, -2, and -3 and 'Improved' included participants with scores of 3, 2, and 1. Higher the GAIS value, the greater the improvement (Range 0 to 3).
Measured: At 6,13 months, 2, 3, 4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start21 May 2015
- Primary completion28 May 2021
- Study completion28 May 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 Fold Contour DeficienciesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 867 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, Study chair, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425943
- Sponsor's protocol ID
- GLI.04.SPR.US10321
- Status last verified
- Jul 2023
- First submitted
- 10 Apr 2015
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Sculptra®Aesthetic in Immuno-Competent Subjects Stratified by Fitzpatrick Skin Type I-VI)
- ClinicalTrials.gov ID
- NCT02425943
- Acronym / sponsor ID
- GLI.04.SPR.US10321
- Conditions
- Nasolabial Fold Contour Deficiencies, Wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 867 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 21 May 2015 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.
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: injectable poly-L-lactic acid Sculptra Aesthetic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Subjects seeking correction of shallow to deep NLF contour deficiencies.
Key exclusion criteria (2 listed)
- Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds.
- Subjects that are less than 18 or greater than 75 years of age.
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 |
|---|---|---|
| injectable poly-L-lactic acid Sculptra AestheticAlso: Sculptra Aesthetic | Device | Sculptra Aesthetic |
Primary outcome
Percentage of Participants With Any Injection Site Nodule and/or Papule
Time frame: Up to 5 years
Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to [>=] 0.5 (cm); papule less than [<] 0.5 cm). Percentage of participants with any injection site nodule and/or papule were reported.
Percentage of Participants With Any Adverse Events of Interest (AEIs)
Time frame: Up to 5 years
AEIs means: "serious or non-serious adverse event that is one of scientific and medical concern specific to the sponsor's product for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Examples of AEIs were hypertrophic scarring, keloid formation, hypersensitivity reactions, skin necrosis, unexpected change in wrinkle contour, granuloma, changes in the skin pigmentation at the site of injection compared to adjacent. Percentage of participants with any AEIs (other than injection site nodule and/or papule) were reported.
6 secondary outcomes
Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
Time frame: Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
Time frame: Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
Time frame: Baseline, Months 6,13 and Years 2,3 4,5
Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
Time frame: Baseline, Months 6,13 and Years 2,3 4,5
Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale
Time frame: At 6,13 months, 2, 3, 4 and 5 years
Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale
Time frame: At 6,13 months, 2, 3, 4 and 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Nasolabial Fold Contour Deficiencies
Active, not recruiting
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Dermal Fillers, Cheek Augmentation
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.
Clinical Operations study chair
Galderma R&D
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing injectable poly-L-lactic acid Sculptra Aesthetic in people with Nasolabial Fold Contour Deficiencies and Wrinkles, run by Galderma R&D at 18 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 2 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). 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?
Percentage of Participants With Any Injection Site Nodule and/or Papule (time frame: Up to 5 years). The study lists 2 primary outcomes in all. 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 27 Jul 2023.