- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444210
DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold Wrinkles
September 14, 2019 updated by: Bausch Health Americas, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
240
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Phyllis Diener, MT, ASCP, Sanofi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Narins 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Study Completion
April 1, 2006
Study Registration Dates
First Submitted
March 5, 2007
First Submitted That Met QC Criteria
March 5, 2007
First Posted (Estimate)
March 7, 2007
Study Record Updates
Last Update Posted (Actual)
September 18, 2019
Last Update Submitted That Met QC Criteria
September 14, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- DL6049-0301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasolabial Fold Wrinkles
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Taipei Medical University HospitalTaipei Medical University; Panion & BF Biotech Inc.Not yet recruitingNasolabial Fold Wrinkles
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Bausch Health Americas, Inc.CompletedNasolabial Fold WrinklesUnited States
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Galderma R&DCompletedWrinkles | Nasolabial Fold Contour DeficienciesUnited States
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Castle Creek Biosciences, LLC.CompletedBilateral Nasolabial Fold WrinklesUnited States
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Castle Creek Biosciences, LLC.CompletedBilateral Nasolabial Fold WrinklesUnited States
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Sadick Research GroupGalderma R&DRecruitingFacial Wrinkles | Nasolabial FoldUnited States
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Medy-ToxCompletedNasolabial FoldKorea, Republic of
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Clinical Trials on DL6049 (injectable poly-L-lactic acid)
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Bausch Health Americas, Inc.CompletedNasolabial Fold WrinklesUnited States
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Bausch Health Americas, Inc.CompletedMid Facial Contour DeficienciesUnited Kingdom
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Taipei Medical University HospitalTaipei Medical University; Panion & BF Biotech Inc.Not yet recruitingNasolabial Fold Wrinkles
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Williams Center Plastic Surgery SpecialistsSanofiCompleted
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Galderma R&DCompletedWrinkles in DecolletageUnited States
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Bausch Health Americas, Inc.Completed
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Galderma Brasil Ltda.Completed
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Bausch Health Americas, Inc.Completed
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Bausch Health Americas, Inc.CompletedFacial LipoatrophyUnited States
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Erevna Innovations Inc.Completed