Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DL6049 · 2 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| DL6049 (injectable poly-L-lactic acid) | DEVICE | - |
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. ...
DL6049 is an investigational product being studied for the treatment of nasolabial fold wrinkles, which are the lines that run from the sides of the nose to the corners of the mouth. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
DL6049 is being developed by Bausch Health Companies Inc., a company publicly traded under the ticker symbol BHC. The company is conducting clinical trials to evaluate the safety and effectiveness of DL6049 for nasolabial fold wrinkles.
DL6049 is in Phase 3 clinical development. It has completed two Phase 3 trials, and it remains an investigational drug, meaning it has not been approved for commercial use. The trials were conducted in the United States with adult participants.
DL6049 has been studied in two completed Phase 3 clinical trials. The first trial, NCT00444210, compared DL6049 to CosmoPlast in the treatment of nasolabial fold wrinkles. The second trial, NCT00444353, was a long-term follow-up study comparing DL6049 to Cosmoplast for the same condition.
No, DL6049 is not the same as CosmoPlast. In clinical trials, DL6049 was compared against CosmoPlast, which served as a comparator product. The trials were designed to evaluate how DL6049 performs relative to CosmoPlast in treating nasolabial fold wrinkles.