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

Galderma

Status and phase: Terminated; Phase 4

Conditions: Nasolabial Folds

Treatments: Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment; Drug: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00716443

US10098

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female Subjects 30 - 65 years of age
• Subject undergoing cosmetic dermal filler injections for correction of nasolabial folds. Treatment sites should be comparable, requiring the same number of injections on each nasolabial fold
• Subjects diagnosed with moderate nasolabial folds (Wrinkle Severity Rating Scale of grade 3)

Exclusion criteria

• Subjects under treatment for a dermatologic condition on the face, which may interfere with the safe evaluation of the study treatment (e.g. eczema, psoriasis, severe sun-damage, dermatitis), have damaged, denuded or broken skin at the designated treatment site and/or have scarring or infection of the area to be treated
• Subjects who have taken prescription or non-prescription analgesic medication during the 24 hour period prior to the procedure
• Subjects with a history of bleeding or clotting disorders
• Subjects who have used ASA (aspirin), NSAIDs (Non-Steroidal Anti- inflammatory Drugs), anticoagulants, St. John's Wort or high doses of Vitamin E (above the recommended daily allowance) within 2 weeks prior to the procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Pliaglis® Cream

Active Comparator group

Description:

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.

Treatment:

Drug: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)

Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment

benzocaine 20% / lidocaine 6% / tetracaine 4% ointment

Active Comparator group

Description:

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.

Treatment:

Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment