Nasolabial Fold WrinklesPhase 3NCT00444210
DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold Wrinkles
A Phase 3 study testing DL6049 (injectable poly-L-lactic acid) in people with Nasolabial Fold Wrinkles, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
This study is being undertaken to: evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment of dermal nasolabial fold wrinkles at 13 months following the last application of study treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasolabial Fold Wrinkles
- What is being tested?
- DL6049 (injectable poly-L-lactic acid)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Apr 2006
- Phase
- Phase 3
- 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
Who may be able to join
- Subjects must sign a statement of IC and HIPAA authorization. In addition subjects must provide a separate release for use of their photographs in publications; any subject has a right to refuse the photo release without jeopardizing their ability to participate in the study.
- Subjects must be 18-75 yrs of age, of any race or sex
- Female subjects must be post-menopausal for at least 1 yr or have had a hysterectomy; or have a had a tubal ligation; or if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e, oral/systemic contraceptives, IUD, or spermicide in combination with barrier method of contraception).
- Subjects seeking augmentation therapy for bilateral correction of nasolabial folds. Subjects must have a score of greater than or equal to 2 and less than or equal to 4 on the photo-numeric wrinkle assessment scale (assessed by a blinded evaluator) of both the left and right nasolabial fold at Visit 1.
Who cannot join
- Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (e.g.,lidocaine, etc.), bovine collagen, latex, silicone, carmellose, or mannitol.
- Subjects with a known history of keloids or bleeding disorders.
- Subjects with an active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease).
- Subjects with active hepatitis within the past year.
- Subjects who are pregnant (confirmation by pregnancy testing),or plan to become pregnant within the study timeframe, or who are nursing.
- 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 with clinically important disease as judged by the investigator within 3 months of the study (e.g., significant lab abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases, etc.) including subjects with medical conditions that might require the use of immunosuppressive medications during the trial (e.g., severe asthma, rheumatoid arthritis, etc.).
- Subjects who have used exclusionary medications/treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of the Safety and Effectiveness of DL6049 (Injectable Poly-L-lactic Acid) Versus CosmoPlast Collagen Implant in the Treatment of Nasolabial Fold Wrinkles
This study is being undertaken to:
- evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment of dermal nasolabial fold wrinkles at 13 months following the last application of study treatment.
- Document the types and incidence of adverse events reported with DL6049 (injectable poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events will be assessed for an additional 12 months following discharge from the main study in subjects treated with DL6049.
- Conditions
- Nasolabial Fold Wrinkles
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Evaluate degree of correction attainable with DL6049 compared to CosmoPlast Collagen Implant; in the treatment of dermal nasolabial fold wrinkles at 13 months following last application of study treatment.
Secondary outcomes (1)
Treatment group comparisons at each timepoint of the treatment success rate (proportion of subjects with a photographic wrinkle severity grade of < 2), mean wrinkle severity grade, and investigator/subject global assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startJun 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasolabial Fold WrinklesStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 240 participants
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
- NCT00444210
- Sponsor's protocol ID
- DL6049-0301
- Status last verified
- Sep 2019
- First submitted
- 5 Mar 2007
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown SA, Rohrich RJ, Baumann L, Brandt FS, Fagien S, Glazer S, Kenkel JM, Lowe NJ, Monheit GD, Narins RS, Rendon MI, Werschler WP. Subject global evaluation and subject satisfaction using injectable poly-L-lactic acid versus human collagen for the correction of nasolabial fold wrinkles. Plast Reconstr Surg. 2011 Apr;127(4):1684-1692. doi: 10.1097/PRS.0b013e318208d371.
PubMed 21460676Narins RS, Baumann L, Brandt FS, Fagien S, Glazer S, Lowe NJ, Monheit GD, Rendon MI, Rohrich RJ, Werschler WP. A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010 Mar;62(3):448-62. doi: 10.1016/j.jaad.2009.07.040.
PubMed 20159311
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 Randomized Study of the Safety and Effectiveness of DL6049 (Injectable Poly-L-lactic Acid) Versus CosmoPlast Collagen Implant in the Treatment of Nasolabial Fold Wrinkles
- ClinicalTrials.gov ID
- NCT00444210
- Acronym / sponsor ID
- DL6049-0301
- Conditions
- Nasolabial Fold Wrinkles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Apr 2006
- First posted
- 7 Mar 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.
This study is being undertaken to:
- evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment of dermal nasolabial fold wrinkles at 13 months following the last application of study treatment.
- Document the types and incidence of adverse events reported with DL6049 (injectable poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events will be assessed for an additional 12 months following discharge from the main study in subjects treated with DL6049.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must sign a statement of IC and HIPAA authorization. In addition subjects must provide a separate release for use of their photographs in publications; any subject has a right to refuse the photo release without jeopardizing their ability to participate in the study.
- Subjects must be 18-75 yrs of age, of any race or sex
- Female subjects must be post-menopausal for at least 1 yr or have had a hysterectomy; or have a had a tubal ligation; or if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e, oral/systemic contraceptives, IUD, or spermicide in combination with barrier method of contraception).
- Subjects seeking augmentation therapy for bilateral correction of nasolabial folds. Subjects must have a score of greater than or equal to 2 and less than or equal to 4 on the photo-numeric wrinkle assessment scale (assessed by a blinded evaluator) of both the left and right nasolabial fold at Visit 1.
Key exclusion criteria (8 listed)
- Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (e.g.,lidocaine, etc.), bovine collagen, latex, silicone, carmellose, or mannitol.
- Subjects with a known history of keloids or bleeding disorders.
- Subjects with an active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease).
- Subjects with active hepatitis within the past year.
- Subjects who are pregnant (confirmation by pregnancy testing),or plan to become pregnant within the study timeframe, or who are nursing.
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) | Device | – |
Primary outcome
Primary: Evaluate degree of correction attainable with DL6049 compared to CosmoPlast Collagen Implant; in the treatment of dermal nasolabial fold wrinkles at 13 months following last application of study treatment.
1 secondary outcome
Treatment group comparisons at each timepoint of the treatment success rate (proportion of subjects with a photographic wrinkle severity grade of < 2), mean wrinkle severity grade, and investigator/subject global assessment
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.
- Derived from this study: PubMed 21460676Brown SA, Rohrich RJ, Baumann L, Brandt FS, Fagien S, Glazer S, Kenkel JM, Lowe NJ, Monheit GD, Narins RS, Rendon MI, Werschler WP. Subject global evaluation and subject satisfaction using injectable poly-L-lactic acid versus human collagen for the correction of nasolabial fold wrinkles. Plast Reconstr Surg. 2011 Apr;127(4):1684-1692. doi: 10.1097/PRS.0b013e318208d371.
- Derived from this study: PubMed 20159311Narins RS, Baumann L, Brandt FS, Fagien S, Glazer S, Lowe NJ, Monheit GD, Rendon MI, Rohrich RJ, Werschler WP. A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010 Mar;62(3):448-62. doi: 10.1016/j.jaad.2009.07.040.
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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.
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?
A Phase 3 study testing DL6049 (injectable poly-L-lactic acid) in people with Nasolabial Fold Wrinkles, run by Bausch Health Americas, Inc. 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 4 inclusion and 8 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Primary: Evaluate degree of correction attainable with DL6049 compared to CosmoPlast Collagen Implant; in the treatment of dermal nasolabial fold wrinkles at 13 months following last application of study treatment.. 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 NCT00444210, which also lists 2 linked publications.
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; AzTrials last refreshed its copy on 8 Nov 2026.