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)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
45 subjects are planned; a portion of these subjects will have skin of color
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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