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NADGL

Phase 3

Facial Wrinkles | Unknown | Other |Sanofi|Last Updated: Mar 5, 2015

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00417469A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)PHASE3 COMPLETED 45 — — Jan 1, 2007Feb 1, 2007Mar 5, 20151 United States
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Study Endpoints
Primary Endpoints
To evaluate the pain experienced during and after the injection procedure for NADGL as compared to Captique® Injectable Gel in subjects undergoing cutaneous correction of nasolabial folds (NLFs).
Secondary Endpoints
To evaluate the safety of NADGL.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
NADGLDEVICE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * bilateral nasolabial folds with severity score of 3 or 4 on the 6 point scale. Exclusion Criteria: * pregnant/lactating women * subjects who have an allergy to lidocaine or other amide-type anesthetics

Countries:United States
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