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DL6049

Phase 3

Nasolabial Fold Wrinkles | Unknown | Other |Bausch Health Companies Inc.|Last Updated: Sep 18, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment480
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00444353DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-upPHASE3 COMPLETED 240 — — Aug 1, 2004Jan 1, 2007Sep 18, 20191 United States
NCT00444210DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold WrinklesPHASE3 COMPLETED 240 — — Jun 1, 2004Apr 1, 2006Sep 18, 20191 United States
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Study Endpoints
Primary Endpoints
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.
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 Endpoints
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 assessments.
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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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
DL6049 (injectable poly-L-lactic acid)DEVICE -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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. ...

Countries:United States
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