DL6049 vs CosmoPlast 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.

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Key information

Conditions

Nasolabial Fold Wrinkles

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DL6049 (injectable poly-L-lactic acid)

Device

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Study completion: 2006
First posted: Mar 7, 2007
Registry last updated: Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed