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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-09-30

Brief Summary

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

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Detailed Description

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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

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Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pliaglis® Cream

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections

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

Intervention Type DRUG

apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections

Interventions

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

Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Pliaglis® Cream BLT ointment

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No