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)

Genzyme, a Sanofi Company45 enrolled

Overview

The purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield, NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by Genzyme Biosurgery. We do not know which of these treatments results in less pain during and after injection. The safety of NADGL is also being studied.

45 subjects are planned; a portion of these subjects will have skin of color

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Facial Wrinkles

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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 Outcomes

To evaluate the safety of NADGL.

Data from ClinicalTrials.gov

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