Conditions: Aging Pain
Keywords: wrinkles dermal filler collagen soft tissue augmentation lidocaine aesthetic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief summary:
The study doctor will give EVOLENCE® mixed with Lidocaine to people in this study to see if it effectively reduces pain while injecting and works to correct nasolabial wrinkles.

The product being used in this study is EVOLENCE®, which is currently marketed in the United States for the cosmetic correction of soft tissue contour deficiencies (including wrinkles), and been approved by the U.S. Food and Drug Administration (FDA).

Detailed description:
The aim of this study is to determine if the admixture of lidocaine can effectively be used to mediate pain relief during the injection of EVOLENCE® while achieving cosmetic correction.

Arms:
arm 1: Assess injection pain severity for a one time 1.0 mL injection of Evolence with 0.2 ml of topical anesthetic, applied 30 minutes prior to injection, to the left nasolabial fold of each participant . arm 2: Assess injection pain severity for a one time 1.0 mL injection of Evolence mixed with 0.18 mL of 2% lidocaine (0.3% final lidocaine-HCl) in the right nasolabial fold of each participant.

Interventions: intervention 1: Evolence intervention 2: Lidocaine intervention 3: topical anesthetic
Intervention descriptions: intervention 1: Injectable collagen intervention 2: admix anesthetic intervention 3: None

Protocol document: