DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold Wrinkles - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00444210

Purpose

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.

Condition	Intervention	Phase
Nasolabial Fold Wrinkles	Device: DL6049 (injectable poly-L-lactic acid)	Phase III

Drug Information available for: Lactic acid Poly-L-lactic acid Ammonium lactate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	240
Study Start Date:	June 2004
Estimated Study Completion Date:	April 2006

Eligibility

Criteria

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444210

Locations

United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Phyllis Diener, MT, ASCP

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	DL6049-0301
Study First Received:	March 5, 2007
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00444210 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 06, 2009