Nasolabial FoldsNCT03780244
Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
A study testing Sculptra Aesthetic 8ml and Sculptra Aesthetic 5ml in people with Nasolabial Folds, run by Galderma R&D at 5 sites in United States.
Trial summary
This study has been designed to evaluate the 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 olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Sculptra Aesthetic 8ml and Sculptra Aesthetic 5ml
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Dec 2018to 28 Feb 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.
Who cannot join
- Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.
- Collagen, Hyaluronic Acid- 12 months
- Calcium Hydroxyapatite (CaHa), Poly-L-lactic Acid (PLLA) or permanent (non-biodegradable)- Prohibited
- Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Galderma Study Site
Austin, Texas, 78746
Galderma Study Site
Bradenton, Florida, 34209
Galderma Study Site
Scottsdale, Arizona, 85255
Galderma Study Site
Solana Beach, California, 92075
Galderma Study Site
Spring, Texas, 77388
About this study
Official title: A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
This study has been designed to evaluate the 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 8ml, Sculptra Aesthetic 5ml
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra Aesthetic 8mlDevice
Treatment of nasolabial folds
Sculptra Aesthetic 5mlDevice
Treatment of nasolabial folds
| Study group | Role | What they receive |
|---|---|---|
| Investigational Study Product | Experimental | Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI) Receives: Device: Sculptra Aesthetic 8ml |
| Reference Product | Active comparator | Injection with Sculptra Aesthetic reconstituted with 5ml SWFI Receives: Device: Sculptra Aesthetic 5ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wrinkle Assessment Scale (WAS) Score
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 and not on a comparison to the baseline appearance.
Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session.
Measured: 48 weeks
Secondary outcomes (17)
Change in Wrinkle Assessment Scale (WAS) Score
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 and not on a comparison to the baseline appearance.
Effectiveness is defined as change from baseline on both sides of the face as assessed by the Blinded Evaluator using WAS at X weeks
Measured: Weeks 16, 24, 32, and 40
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the subject
Measured: Weeks 16, 24, 32, 40, and 48.
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Treating Investigator
Measured: Weeks 16, 24, 32, 40 and 48
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction
Measured: Baseline and at weeks 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
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.
Measured: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.
Measured: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You do the Treatment Again?
A subject satisfaction question with responses Yes or No.
Measured: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
A subject satisfaction question with responses Yes or No.
Measured: Week 16, 24, 32, 40 and 48
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting
Subjects were asked to complete the following questions in the subject diary:
- Did you feel comfortable to return to social engagement today? (Yes or No)
- If yes, what was the earliest time you felt comfortable to return to social engagement? (Record date and time [using 24-hour clock])
Measured: time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start18 Dec 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
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.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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
- NCT03780244
- Sponsor's protocol ID
- 43USSA1705
- Status last verified
- Oct 2022
- First submitted
- 17 Dec 2018
- Last updated
- 14 Nov 2022
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
- ClinicalTrials.gov ID
- NCT03780244
- Acronym / sponsor ID
- 43USSA1705
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been designed to evaluate the 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Study Product | Experimental | Device: Sculptra Aesthetic 8mlInjection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI) |
| Reference Product | Active comparator | Device: Sculptra Aesthetic 5mlInjection with Sculptra Aesthetic reconstituted with 5ml SWFI |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.
Key exclusion criteria (4 listed)
- Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.
- Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
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 8mlTreatment of nasolabial folds | Device | Investigational Study Product |
| Sculptra Aesthetic 5mlTreatment of nasolabial folds | Device | Reference Product |
Primary outcome
Change in Wrinkle Assessment Scale (WAS) Score
Time frame: 48 weeks
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 and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session.
17 secondary outcomes
Change in Wrinkle Assessment Scale (WAS) Score
Time frame: Weeks 16, 24, 32, and 40
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
Time frame: Weeks 16, 24, 32, 40, and 48.
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
Time frame: Weeks 16, 24, 32, 40 and 48
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Time frame: Baseline and at weeks 24, 32, 40 and 48
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You do the Treatment Again?
Time frame: Week 16, 24, 32, 40 and 48
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
Time frame: Week 16, 24, 32, 40 and 48
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting
Time frame: time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- 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.
5 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 8ml and Sculptra Aesthetic 5ml in people with Nasolabial Folds, run by Galderma R&D at 5 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 4 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 14 Nov 2022). 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 in Wrinkle Assessment Scale (WAS) Score (time frame: 48 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 14 Nov 2022.