Mid Facial Contour DeficienciesNCT00487474
A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of SCULPTRA Measured by Three Dimensional Digital Surface Imaging
An observational study of Mid Facial Contour Deficiencies, run by Bausch Health Americas, Inc. at 1 site in United Kingdom.
Trial summary
Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging Determine the mean change from baseline in facial contour deficiency as measured by the Dermik Nasolabial Photo-numeric Scale Correlate volumetric correction with clinical improvement as measured by… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mid Facial Contour Deficiencies
- What is being tested?
- DL6049 (injectable poly-L-lactic acid)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2007to Feb 2008
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with signs of facial contour deficiencies in the area of the nasolabial folds [nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale.
Who may be able to join
- Subjects must sign a statement of informed consent.
- Subjects must be 18-75 years of age, of any race or gender.
- Female patients of childbearing potential must have a negative urine pregnancy test prior to the first treatment with the product and must use an acceptable form of birth control throughout the study (e.g., oral/systemic contraceptives, an intrauterine device (IUD) or Norplant starting at least 28 days prior to study entry and throughout the study).
- Subjects must display signs of facial contour deficiencies in the area of the nasolabial folds [nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale.
- Subjects must be a suitable candidate for SCULPTRA treatment.
- Subjects must be able to understand the requirements of the study and be willing to comply with the study requirements
Who cannot join
- Subjects with an allergy to any of the constituents of the product.
- Subjects with a known history of keloids or bleeding disorders.
- Subjects of childbearing potential who are pregnant, or plan to become pregnant within the study timeframe, or who are nursing.
- Subjects with significant facial hair (e.g. mustaches, beards, etc.)
- Subjects with an active inflammatory process or infection in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease in the treatment area).
- Subjects who plan to undergo major facial surgery [e.g., rhinoplasty (with or without implant), facelift, congenital defect repair, etc.] during the course of the study.
- Subjects who have used or plan to use exclusionary medications/treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of Sculptra (Poly-L-lactic Acid) Measured by Three Dimensional Digital Surface Imaging
- Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging
- Determine the mean change from baseline in facial contour deficiency as measured by the Dermik Nasolabial Photo-numeric Scale
- Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale
- Correlate the mean volumetric change in mid-facial treatment area with the amount of product used
- Evaluate subject and investigator global assessment of improvement and subject treatment satisfaction at the end of treatment
- Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment
- Collect safety data
- Conditions
- Mid Facial Contour Deficiencies
- Being tested
- DL6049 (injectable poly-L-lactic acid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DL6049 (injectable poly-L-lactic acid)Device
Also called Sculptra
Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert
| Study group | Role | What they receive |
|---|---|---|
| Sculptra | Not described Receives: Device: DL6049 (injectable poly-L-lactic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.
Measured: 6 months
Secondary outcomes (14)
Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging
Measured: 6 months
Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale.
Measured: 6 months
Correlate the mean volumetric change in mid-facial treatment area with the amount of product used.
Measured: 6 months
Determine mean change from baseline in the contour deficiency score as determined by the investigator.
Measured: 6 months
Investigator Global Assessment of Improvement - Excellent Improvement
Measured: 6 months
Investigator Global Assessment of Improvement - Much Improved
Measured: 6 Months
Investigator Global Assessment of Improvement - Improved
Measured: 6 Months
Investigator Global Assessment of Improvement - No Change
Measured: 6 Months
Investigator Global Assessment of Improvement - Worse
Measured: 6 Months
Subject Global Assessment of Improvement - Excellent Improvement
Measured: 6 Months
Subject Global Assessment of Improvement - Much Improved
Measured: 6 Months
Subject Global Assessment of Improvement - Improved
Measured: 6 Months
Subject Global Assessment of Improvement - No Change
Measured: 6 Months
Subject Global Assessment of Improvement - Worse
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid Facial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phyllis Diener, MT, ASCP, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487474
- Sponsor's protocol ID
- DL6049-0502
- Status last verified
- Sep 2019
- First submitted
- 15 Jun 2007
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of Sculptra (Poly-L-lactic Acid) Measured by Three Dimensional Digital Surface Imaging
- ClinicalTrials.gov ID
- NCT00487474
- Acronym / sponsor ID
- DL6049-0502
- Conditions
- Mid Facial Contour Deficiencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 18 Jun 2007 (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.
- Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging
- Determine the mean change from baseline in facial contour deficiency as measured by the Dermik Nasolabial Photo-numeric Scale
- Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale
- Correlate the mean volumetric change in mid-facial treatment area with the amount of product used
- Evaluate subject and investigator global assessment of improvement and subject treatment satisfaction at the end of treatment
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sculptra | – | Device: DL6049 (injectable poly-L-lactic acid) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with signs of facial contour deficiencies in the area of the nasolabial folds [nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale.
Key inclusion criteria (6 listed)
- Subjects must sign a statement of informed consent.
- Subjects must be 18-75 years of age, of any race or gender.
- Female patients of childbearing potential must have a negative urine pregnancy test prior to the first treatment with the product and must use an acceptable form of birth control throughout the study (e.g., oral/systemic contraceptives, an intrauterine device (IUD) or Norplant starting at least 28 days prior to study entry and throughout the study).
- Subjects must display signs of facial contour deficiencies in the area of the nasolabial folds [nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale.
- Subjects must be a suitable candidate for SCULPTRA treatment.
Key exclusion criteria (7 listed)
- Subjects with an allergy to any of the constituents of the product.
- Subjects with a known history of keloids or bleeding disorders.
- Subjects of childbearing potential who are pregnant, or plan to become pregnant within the study timeframe, or who are nursing.
- Subjects with significant facial hair (e.g. mustaches, beards, etc.)
- Subjects with an active inflammatory process or infection in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease in the treatment area).
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 |
|---|---|---|
| DL6049 (injectable poly-L-lactic acid)Also: SculptraSubjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert | Device | Sculptra |
Primary outcome
Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.
Time frame: 6 months
14 secondary outcomes
Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging
Time frame: 6 months
Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale.
Time frame: 6 months
Correlate the mean volumetric change in mid-facial treatment area with the amount of product used.
Time frame: 6 months
Determine mean change from baseline in the contour deficiency score as determined by the investigator.
Time frame: 6 months
Investigator Global Assessment of Improvement - Excellent Improvement
Time frame: 6 months
Investigator Global Assessment of Improvement - Much Improved
Time frame: 6 Months
Investigator Global Assessment of Improvement - Improved
Time frame: 6 Months
Investigator Global Assessment of Improvement - No Change
Time frame: 6 Months
Investigator Global Assessment of Improvement - Worse
Time frame: 6 Months
Subject Global Assessment of Improvement - Excellent Improvement
Time frame: 6 Months
Subject Global Assessment of Improvement - Much Improved
Time frame: 6 Months
Subject Global Assessment of Improvement - Improved
Time frame: 6 Months
Subject Global Assessment of Improvement - No Change
Time frame: 6 Months
Subject Global Assessment of Improvement - Worse
Time frame: 6 Months
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 18 Sep 2019.
Related trials for Mid Facial 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.
Phyllis Diener, MT, ASCP study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mid Facial Contour Deficiencies, run by Bausch Health Americas, Inc. at 1 site in United Kingdom.
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 6 inclusion and 7 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 18 Sep 2019. 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 Kingdom. 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?
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?
Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging. (time frame: 6 months). 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 18 Sep 2019.