Open-Label, Randomized, Split-Face Study to Evaluate the Efficacy, Safety and Subject Satisfaction of Pain Management During and After Restylane® Dermal Filler Injections for the Correction of Nasolabial Folds
Open-label, randomized study designed to assess the effectiveness of a topical anesthetic
(Pliaglis® Cream) versus a compounded topical anesthetic at needle stick, immediately after,
one and three hours after Restylane® injections in the nasolabial folds.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds
Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds
upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds
Ronald W Gottschalk, MD
Galderma Laboratories, L.P.
United States: Institutional Review Board
|Premier Clinical Research||Spokane, Washington 99204|
|Skin and Cancer Associates, Center for Cosmetic Enhancement||Aventura, Florida 33180|
|Palm Beach Esthetic Dermatology and Laser Center||West Palm Beach, Florida 33401|
|Sadick Dermatology||New York, New York 10021|