- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00716443
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
July 28, 2022 updated by: Galderma R&D
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
Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Aventura, Florida, United States, 33180
- Skin and Cancer Associates, Center for Cosmetic Enhancement
-
West Palm Beach, Florida, United States, 33401
- Palm Beach Esthetic Dermatology and Laser Center
-
-
New York
-
New York, New York, United States, 10021
- Sadick Dermatology
-
-
Washington
-
Spokane, Washington, United States, 99204
- Premier Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections
Other Names:
apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections
Other Names:
|
Active Comparator: 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.
|
apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections
Other Names:
|
What is the study measuring?
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: three hours after injection of Restylane® into the 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Day of injection of Restylane® into the 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
July 14, 2008
First Submitted That Met QC Criteria
July 15, 2008
First Posted (Estimate)
July 16, 2008
Study Record Updates
Last Update Posted (Actual)
August 23, 2022
Last Update Submitted That Met QC Criteria
July 28, 2022
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Benzocaine
- Tetracaine
Other Study ID Numbers
- US10098
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasolabial Folds
-
Teoxane SARecruiting
-
Samyang Biopharmaceuticals CorporationNot yet recruiting
-
AbbVieRecruiting
-
Galderma R&DCompleted
-
Allergan MedicalCompleted
-
Sewon Cellontech Co., Ltd.CompletedNasolabial FoldsKorea, Republic of
-
HugelJworldRecruitingNasolabial FoldsKorea, Republic of
-
Samyang Biopharmaceuticals CorporationNot yet recruiting
Clinical Trials on tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)
-
Erasmus Medical CenterCompletedAcne Keloidalis Nuchae | TattooNetherlands
-
ZARS Pharma Inc.Completed
-
ZARS Pharma Inc.CompletedPostherpetic NeuralgiaUnited States
-
ZARS Pharma Inc.Completed
-
ZARS Pharma Inc.Completed
-
ZARS Pharma Inc.Completed
-
ZARS Pharma Inc.Completed
-
Bitop AGCompletedAtopic Dermatitis EczemaGermany
-
ZARS Pharma Inc.Completed