Conditions: Nasolabial Folds
Keywords: Nasolabial folds wrinkles topical anesthetic
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 51
Healthy volunteers: no

Brief 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.

Arms:
arm 1: tetracaine 4% / lidocaine 7% cream; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face. arm 2: apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face.

Interventions: intervention 1: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream) intervention 2: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
Intervention descriptions: intervention 1: Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections intervention 2: apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections

Protocol document: