NCT00716443

Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.

Detailed description

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.

Conditions

• Nasolabial Folds

Interventions

Type	Name	Description
DRUG	tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)	Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections
DRUG	benzocaine 20% / lidocaine 6% / tetracaine 4% ointment	apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-07-16
• Last updated: 2022-08-23
• Results posted: 2010-02-01

Locations

4 sites across 1 country: United States