Healthy VolunteersNCT00869687
Biopsy Study for Sculptra (Poly-L-Lactic Acid)
A study testing Poly-L-Lactic Acid Injection in people with Healthy Volunteers, run by Bausch Health Americas, Inc. at 1 site in Canada.
Trial summary
The primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Sculptra (Poly-L-Lactic Acid or PLLA). Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Poly-L-Lactic Acid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to May 2010
- Phase
- Interventional
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- If female, the subject must use appropriate form of birth control.
Who cannot join
- History of allergies or an allergic reaction to local numbing medications (e.g., lidocaine, etc.), latex, or silicone.
- History of forming large scars following an accident or surgery.
- History of any bleeding problems.
- Redness, swelling, or signs of infection behind the right or left ear between the area of the earlobe and hairline.
- Pimples, rashes, scarring or any other skin changes behind the right or left ear between the area of the earlobe and hairline.
- History of any medical problems (for example, heart attack, stroke, diabetes/high blood sugar, hepatitis, human immunodeficiency virus (HIV), severe asthma, rheumatoid arthritis, emphysema, breathing problems). Subjects with high blood pressure or high cholesterol may qualify for the study if there have been no changes in their medications for three (3) months.
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- History of cancer within five (5) years.
- Previous cosmetic surgery or cosmetic procedures affecting the area behind the ear.
- Subject who plans to have any facial or ear surgery within the next year.
- History of alcohol or drug abuse.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Group Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid (Sculptra) in Healthy Volunteers
The primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study are to better understand the human skin responses to Sculptra and to assess the safety of Sculptra injections.
- Conditions
- Healthy Volunteers
- Being tested
- Poly-L-Lactic Acid Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-Lactic Acid InjectionDevice
0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL).
| Study group | Role | What they receive |
|---|---|---|
| Poly-L-Lactic Acid Injection | Other | Not described Receives: Device: Poly-L-Lactic Acid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen.
Measured: 6 months
Secondary outcomes (5)
Change from baseline in level of Type 1 collagen at 3 months and 12 months
Measured: 3 and 12 months
Change from baseline in level of Type III collagen at 3 months, 6 months, & 12 months by immunohistochemistry in a central laboratory.
Measured: 3, 6, and 12 months
Qualitative assessment in degree of change from baseline in Type I collagen at 3 months, 6 months, & 12 months by a pathologist.
Measured: 3, 6, and 12 months
Degree of inflammation assessed by histology at 3 months, 6 months, and 12 months.
Measured: 3, 6, and 12 months
Qualitative assessment in degree of change from baseline in Type III collagen at 3 months, 6 months, & 12 months by a pathologist.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tara Semanchik, MBA, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869687
- Sponsor's protocol ID
- POLYL_L_02888
- Status last verified
- Nov 2019
- First submitted
- 25 Mar 2009
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid (Sculptra) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00869687
- Acronym / sponsor ID
- POLYL_L_02888
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Mar 2009 (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 primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study are to better understand the human skin responses to Sculptra and to assess the safety of Sculptra injections.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poly-L-Lactic Acid Injection | Other | Device: Poly-L-Lactic Acid Injection |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- If female, the subject must use appropriate form of birth control.
Key exclusion criteria (11 listed)
- History of allergies or an allergic reaction to local numbing medications (e.g., lidocaine, etc.), latex, or silicone.
- History of forming large scars following an accident or surgery.
- History of any bleeding problems.
- Redness, swelling, or signs of infection behind the right or left ear between the area of the earlobe and hairline.
- Pimples, rashes, scarring or any other skin changes behind the right or left ear between the area of the earlobe and hairline.
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 |
|---|---|---|
| Poly-L-Lactic Acid Injection0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL). | Device | Poly-L-Lactic Acid Injection |
Primary outcome
Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen.
Time frame: 6 months
5 secondary outcomes
Change from baseline in level of Type 1 collagen at 3 months and 12 months
Time frame: 3 and 12 months
Change from baseline in level of Type III collagen at 3 months, 6 months, & 12 months by immunohistochemistry in a central laboratory.
Time frame: 3, 6, and 12 months
Qualitative assessment in degree of change from baseline in Type I collagen at 3 months, 6 months, & 12 months by a pathologist.
Time frame: 3, 6, and 12 months
Degree of inflammation assessed by histology at 3 months, 6 months, and 12 months.
Time frame: 3, 6, and 12 months
Qualitative assessment in degree of change from baseline in Type III collagen at 3 months, 6 months, & 12 months by a pathologist.
Time frame: 3, 6, and 12 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 20 Nov 2019.
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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.
Tara Semanchik, MBA study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-L-Lactic Acid Injection in people with Healthy Volunteers, run by Bausch Health Americas, Inc. at 1 site in Canada.
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 11 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 20 Nov 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 Canada. 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?
Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen. (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 20 Nov 2019.