Problem of AgingPhase 4NCT01307865
Volume Restoration of the Aging Midface With Sculptra Aesthetic
A Phase 4 study testing injectable poly-L-lactic acid in people with Problem of Aging, run by Williams Center Plastic Surgery Specialists at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic rejuvenation of the midface complex. The investigators plan to both qualitatively determine the restoration of midface architecture as well as quantitatively document the change in midface volume by employing three-dimensional… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem of Aging
- What is being tested?
- injectable poly-L-lactic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 40-60 years old
- BMI greater than 18.5 and less than 24.9
Who cannot join
- Age less than 40 years or greater than 60 years
- Prior surgical or non-surgical treatment to the midface within the past 2 years
- Interested in seeking other treatments to the midface during the study period
- Pregnant, lactating, or breast feeding
- Hypersensitivity to poly-L-lactic acid, carboxymethylcellulose, or mannitol
- Allergy to lidocaine or epinephrine
Show all 16Show fewer
- History of atopy, anaphylaxis, or multiple severe allergies
- Current immunotherapy or history of autoimmune disease
- History of or active stroke or myocardial infarction
- History of or active connective tissue disease
- History of or active bleeding disorders
- History of or active cancer
- Serious abnormalities in laboratory findings
- Active hepatitis
- Active infection or inflammatory process of skin
- History of or risk factors for hypertrophic scarring or keloid formation
Trial locations and contacts
1 site in 1 country.
United States1 site
Williams Center Plastic Surgery Specialists
Latham, New York, 12110
About this study
The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic rejuvenation of the midface complex. The investigators plan to both qualitatively determine the restoration of midface architecture as well as quantitatively document the change in midface volume by employing three-dimensional (3D) surface imaging which critically analyzes volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic injections will experience significant improvement in facial midface volume restoration.
- Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
- Determine the mean change from baseline in facial contour via quantitative volumetric measurements
- Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system
- Correlate the mean volumetric change in midfacial treatment area with the amount of product used
- Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment
- Collect safety data
- Conditions
- Problem of Aging
- Being tested
- injectable poly-L-lactic acid
- Keywords
- midface volume loss, aging of midface, sculptra, sculptra aesthetic, poly-L-lactic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable poly-L-lactic acidDrug
Also called Sculptra Aesthetic, Sculptra, Poly-L-lactic acid
Each patient will receive up to 1 vial of Sculptra Aesthetic total to both midface complexes at each of 3 treatment sessions, spaced 6 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Sculptra Aesthetic | Experimental | Patients receiving Sculptra Aesthetic Receives: Drug: injectable poly-L-lactic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in midfacial volume from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
Measured: 6 mo, 9 mo, 12 mo, 15 mo
Secondary outcomes (6)
Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system
Measured: 12 mo
Correlate the mean volumetric change in midfacial volume with the amount of product used
Measured: 12 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Measured: 6 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Measured: 9 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Measured: 12 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Measured: 15 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problem of AgingStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Williams Center Plastic Surgery Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Edwin F. Williams, III, M.D., Williams Center Plastic Surgery Specialists
- Investigators
- Edwin F Williams, MD, Principal investigator, Williams Center Plastic Surgery Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307865
- Sponsor's protocol ID
- EFW-001-SA
- Status last verified
- Oct 2013
- First submitted
- 2 Mar 2011
- Last updated
- 16 Oct 2013
- Results posted
- No
Publications
Chen HH, Javadi P, Daines SM, Williams EF 3rd. Quantitative assessment of the longevity of poly-L-lactic acid as a volumizing filler using 3-dimensional photography. JAMA Facial Plast Surg. 2015 Jan-Feb;17(1):39-43. doi: 10.1001/jamafacial.2014.867.
PubMed 25340593
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Restoration of the Aging Midface With Sculptra Aesthetic
- ClinicalTrials.gov ID
- NCT01307865
- Acronym / sponsor ID
- EFW-001-SA
- Conditions
- Problem of Aging
- Keywords
- midface volume loss, aging of midface, sculptra, sculptra aesthetic, poly-L-lactic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Williams Center Plastic Surgery SpecialistsUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic rejuvenation of the midface complex. The investigators plan to both qualitatively determine the restoration of midface architecture as well as quantitatively document the change in midface volume by employing three-dimensional (3D) surface imaging which critically analyzes volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic injections will experience significant improvement in facial midface volume restoration.
- Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
- Determine the mean change from baseline in facial contour via quantitative volumetric measurements
- Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system
- Correlate the mean volumetric change in midfacial treatment area with the amount of product used
- Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment
- Collect safety data
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 | Drug: injectable poly-L-lactic acidPatients receiving Sculptra Aesthetic |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 40-60 years old
- BMI greater than 18.5 and less than 24.9
Key exclusion criteria (16 listed)
- Age less than 40 years or greater than 60 years
- Prior surgical or non-surgical treatment to the midface within the past 2 years
- Interested in seeking other treatments to the midface during the study period
- Pregnant, lactating, or breast feeding
- Hypersensitivity to poly-L-lactic acid, carboxymethylcellulose, or mannitol
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 acidAlso: Sculptra Aesthetic, Sculptra, Poly-L-lactic acidEach patient will receive up to 1 vial of Sculptra Aesthetic total to both midface complexes at each of 3 treatment sessions, spaced 6 weeks apart. | Drug | Sculptra Aesthetic |
Primary outcome
Change from baseline in midfacial volume from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
Time frame: 6 mo, 9 mo, 12 mo, 15 mo
6 secondary outcomes
Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system
Time frame: 12 mo
Correlate the mean volumetric change in midfacial volume with the amount of product used
Time frame: 12 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Time frame: 6 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Time frame: 9 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Time frame: 12 mo
Time course and duration of volumetric correction from Sculptra Aesthetic treatment
Time frame: 15 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Derived from this study: PubMed 25340593Chen HH, Javadi P, Daines SM, Williams EF 3rd. Quantitative assessment of the longevity of poly-L-lactic acid as a volumizing filler using 3-dimensional photography. JAMA Facial Plast Surg. 2015 Jan-Feb;17(1):39-43. doi: 10.1001/jamafacial.2014.867.
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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.
Edwin F Williams, MD principal investigator
Williams Center Plastic Surgery Specialists
1 site 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 in people with Problem of Aging, run by Williams Center Plastic Surgery Specialists at 1 site 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 16 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 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in midfacial volume from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging (time frame: 6 mo, 9 mo, 12 mo, 15 mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307865, which also lists 1 linked publication.
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 16 Oct 2013.