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

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

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.

Official Title
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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

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Drug: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)
* Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pliaglis® Cream<br>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. | Drug: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)<br>* Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections<br>* Other names: Pliaglis® Cream;Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment<br>* apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections<br>* Other names: BLT ointment;|
| Active Comparator: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment<br>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. | Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment<br>* apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections<br>* Other names: BLT ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds | Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds | upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Answered the Question What Level of Pain Did You Experience When You Were Injected? Three Hours After Injection of Restylane® Into the Nasolabial Folds | Number of participants who answered according to a scale of None, Minimal, Mild, Moderate, Severe, or No response to the question What level of pain did you experience when you were injected? three hours after injection of Restylane® into the nasolabial folds | three hours after injection of Restylane® into the nasolabial folds | 
| Number of Participants Who Answered the Question If You Experienced Pain, Was it What You Expected From the Injection Procedure? Three Hours After Injection of Restylane® Into the Nasolabial Folds | Number of participants who answered No, Yes, Had no expectations or No response to the question If you experienced pain, was it what you expected from the injection procedure? three hours after injection of Restylane® into the nasolabial folds | three hours after injection of Restylane® into the nasolabial folds | 
| Number of Participants Who Answered the Question If it Was Different Than What You Expected, Was it? Three Hours After Injection of Restylane® Into the Nasolabial Folds | Number of participants who answered the question If it was different than what you expected, was it? (More pain, Less pain or No response) three hours after injection of Restylane® into the nasolabial folds | three hours after injection of Restylane® into the nasolabial folds | 
| Number of Participants Who Answered the Question Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member? 3 Hours After Injection of Restylane® Into Nasolabial Folds | Number of participants who answered No, Yes or No response to the question Still speaking to the topical anesthetic you had on the right/left side of your face, would you recommend it to your friend or family member? three hours after injection of Restylane® into the nasolabial folds | three hours after injection of Restylane® into the nasolabial folds | 
| Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds | Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds | Upon first needle stick of injection of Restylane® into the nasolabial folds | 
| Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds | Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds immediately after injection of Restylane® into the nasolabial folds | immediately after injection of Restylane® into the nasolabial folds | 
| Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds | Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after injection of Restylane® into the nasolabial folds | one hour after injection of Restylane® into the nasolabial folds | 
| Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds | Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds | three hours after injection of Restylane® into the nasolabial folds | 
| Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds | Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds | upon first needle stick of injection of Restylane® into the nasolabial folds | 
| Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds | Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds | immediately after injection of Restylane® into the nasolabial folds | 
| Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds | Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after an injection of Restylane® into the nasolabial folds | one hour after injection of Restylane® into the nasolabial folds | 
| Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds | Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds | three hours after injection of Restylane® into the nasolabial folds | 
| Number of Participants With Yes/no Answers to Question to Investigator Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure? Day of Injection of Restylane® Into Nasolabial Folds | Number of participants with yes or no answers to question asked to investigator on the day of injection of Restylane® into the nasolabial folds Did the topical anesthetics provided adequate anesthesia for the injections of Restylane® into the nasolabial folds procedure? | Day of injection of Restylane® into the nasolabial folds | 
| Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds | Number of participants w/ tolerability assessments (erythema, edema, blanching) resulting in adverse events from Baseline to two days after injection of Restylane® into the nasolabial folds | Baseline to two days after injection of Restylane® into the nasolabial folds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrinkles, Nasolabial folds, topical anesthetic