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Completed Phase 3 Interventional

DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up

ClinicalTrials.gov ID: NCT00444353

Public ClinicalTrials.gov record NCT00444353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 (Long Term Follow-up)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00444353
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
240 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2004
Primary completion
Not listed
Completion
Dec 31, 2006
Last update posted
Sep 17, 2019

2004 – 2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Sanofi-Aventis Bridgewater New Jersey 08807

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00444353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 17, 2019 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00444353 live on ClinicalTrials.gov.

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