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NADGL

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

NADGL · 1 trial · 1 indication

Phase 3 1
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)Facial Wrinkles
COMPLETED45 Analytics
PHASE3COMPLETED
A 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)
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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 to 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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Frequently asked questions about NADGL

What is NADGL used for?

NADGL is an investigational product studied for the correction of facial wrinkles, specifically nasolabial folds (NLFs), which are the lines that run from the sides of the nose to the corners of the mouth. It is being developed by Sanofi (SNY) and is currently in Phase 3 clinical development.

Who makes NADGL?

NADGL is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. The product is currently in Phase 3 clinical development for the correction of facial wrinkles, specifically nasolabial folds.

What phase is NADGL in?

NADGL is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. A Phase 3 clinical trial for the correction of nasolabial folds has been completed, but the product remains under investigation.

What clinical trials is NADGL in?

NADGL has been studied in a completed Phase 3 clinical trial registered as NCT00417469. This trial, conducted in the United States, enrolled 45 participants to compare subject comfort during and after injections with the study products and to evaluate the safety of the product for the correction of nasolabial folds.

Is NADGL the same as other wrinkle treatments?

NADGL is an investigational product being developed for the correction of facial wrinkles, specifically nasolabial folds. It is not the same as other approved wrinkle treatments, as it is still in clinical development and has not been approved for use. Its safety and efficacy are being evaluated in clinical trials.