Nasolabial Folds
Conditions
Keywords
Nasolabial folds, wrinkles, topical anesthetic
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.
Interventions
DRUGtetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)
Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections
DRUGbenzocaine 20% / lidocaine 6% / tetracaine 4% ointment
apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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? |
| Number of Participants With Tolerability Assessments 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 | 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 |
| 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 | 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 |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: First subject was enrolled on July 30, 2008 and the last subject was enrolled on September 8, 2008.
Pre-assignment details
The wash-out period prior to baseline was 24 hrs for analgesic medication; 14 days for aspirin (ASA), non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants, St. John's Wort or doses of Vitamin E above the recommended daily allowance; 14 days for sunburn/tanning bed exposure; 12 months for filler injections into the nasolabial folds.
Participants by arm
| Arm | Count |
|---|---|
| Pliaglis® Cream and Compounded Topical Anesthetic Ointment Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Pliaglis® Cream and Compounded Topical Anesthetic Ointment |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 8.34 |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
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
Time frame: upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pliaglis® Cream | 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 | upon first needle stick | 2.3 centimeters | Standard Deviation 2.07 |
| Pliaglis® Cream | 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 | immediately after injection | 2.7 centimeters | Standard Deviation 2.14 |
| Pliaglis® Cream | 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 | one hour after injection | 0.8 centimeters | Standard Deviation 1.12 |
| Pliaglis® Cream | 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 | three hours after injection | 0.5 centimeters | Standard Deviation 1.14 |
| Compounded Topical Anesthetic Ointment | 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 | three hours after injection | 0.5 centimeters | Standard Deviation 0.91 |
| Compounded Topical Anesthetic Ointment | 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 | upon first needle stick | 2.8 centimeters | Standard Deviation 2.17 |
| Compounded Topical Anesthetic Ointment | 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 | one hour after injection | 0.6 centimeters | Standard Deviation 0.93 |
| Compounded Topical Anesthetic Ointment | 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 | immediately after injection | 2.8 centimeters | Standard Deviation 2.22 |
Secondary
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
Time frame: immediately after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No pain | 35 participants |
| Pliaglis® Cream | 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 | Slight pain | 11 participants |
| Pliaglis® Cream | 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 | Moderate pain | 5 participants |
| Pliaglis® Cream | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe pain | 1 participants |
| Compounded Topical Anesthetic Ointment | 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 | No pain | 28 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate pain | 4 participants |
| Compounded Topical Anesthetic Ointment | 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 | Slight pain | 18 participants |
Secondary
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
Time frame: one hour after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No pain | 49 participants |
| Pliaglis® Cream | 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 | Slight pain | 2 participants |
| Pliaglis® Cream | 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 | Moderate pain | 0 participants |
| Pliaglis® Cream | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | No pain | 49 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Slight pain | 2 participants |
Secondary
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
Time frame: three hours after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No pain | 50 participants |
| Pliaglis® Cream | 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 | Mild pain | 1 participants |
| Pliaglis® Cream | 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 | Moderate pain | 0 participants |
| Pliaglis® Cream | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | No pain | 50 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Mild pain | 1 participants |
Secondary
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
Time frame: upon first needle stick of injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No pain | 14 participants |
| Pliaglis® Cream | 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 | Mild pain | 31 participants |
| Pliaglis® Cream | 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 | Moderate pain | 6 participants |
| Pliaglis® Cream | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | No pain | 9 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate pain | 13 participants |
| Compounded Topical Anesthetic Ointment | 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 | Mild pain | 29 participants |
Secondary
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
Time frame: immediately after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No pain | 35 participants |
| Pliaglis® Cream | 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 | Slight pain | 10 participants |
| Pliaglis® Cream | 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 | Moderate pain | 6 participants |
| Pliaglis® Cream | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | No pain | 29 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate pain | 7 participants |
| Compounded Topical Anesthetic Ointment | 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 | Slight pain | 15 participants |
Secondary
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
Time frame: Upon first needle stick of injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No pain | 17 participants |
| Pliaglis® Cream | 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 | Slight pain | 28 participants |
| Pliaglis® Cream | 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 | Moderate pain | 6 participants |
| Pliaglis® Cream | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe pain | 1 participants |
| Compounded Topical Anesthetic Ointment | 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 | No pain | 13 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate pain | 12 participants |
| Compounded Topical Anesthetic Ointment | 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 | Slight pain | 25 participants |
Secondary
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
Time frame: one hour after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No pain | 49 participants |
| Pliaglis® Cream | 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 | Slight pain | 2 participants |
| Pliaglis® Cream | 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 | Moderate pain | 0 participants |
| Pliaglis® Cream | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | No pain | 49 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Slight pain | 2 participants |
Secondary
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
Time frame: three hours after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No pain | 50 participants |
| Pliaglis® Cream | 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 | Mild pain | 1 participants |
| Pliaglis® Cream | 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 | Moderate pain | 0 participants |
| Pliaglis® Cream | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | No pain | 49 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate pain | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Mild pain | 2 participants |
Secondary
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
Time frame: three hours after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | More pain | 10 participants |
| Pliaglis® Cream | 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 | Less pain | 14 participants |
| Pliaglis® Cream | 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 | No response | 27 participants |
| Compounded Topical Anesthetic Ointment | 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 | More pain | 9 participants |
| Compounded Topical Anesthetic Ointment | 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 | Less pain | 14 participants |
| Compounded Topical Anesthetic Ointment | 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 | No response | 28 participants |
Secondary
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
Time frame: three hours after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No | 10 participants |
| Pliaglis® Cream | 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 | Yes | 27 participants |
| Pliaglis® Cream | 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 | Had no expectations | 12 participants |
| Pliaglis® Cream | 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 | No response | 2 participants |
| Compounded Topical Anesthetic Ointment | 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 | No response | 1 participants |
| Compounded Topical Anesthetic Ointment | 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 | No | 8 participants |
| Compounded Topical Anesthetic Ointment | 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 | Had no expectations | 13 participants |
| Compounded Topical Anesthetic Ointment | 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 | Yes | 29 participants |
Secondary
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
Time frame: three hours after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | No | 13 participants |
| Pliaglis® Cream | 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 | Yes | 38 participants |
| Pliaglis® Cream | 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 | No response | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | No | 12 participants |
| Compounded Topical Anesthetic Ointment | 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 | Yes | 39 participants |
| Compounded Topical Anesthetic Ointment | 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 | No response | 0 participants |
Secondary
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
Time frame: three hours after injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | None | 4 participants |
| Pliaglis® Cream | 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 | Minimal | 23 participants |
| Pliaglis® Cream | 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 | Mild | 15 participants |
| Pliaglis® Cream | 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 | Moderate | 8 participants |
| Pliaglis® Cream | 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 | Severe | 1 participants |
| Pliaglis® Cream | 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 | No response | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Severe | 1 participants |
| Compounded Topical Anesthetic Ointment | 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 | None | 2 participants |
| Compounded Topical Anesthetic Ointment | 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 | Moderate | 9 participants |
| Compounded Topical Anesthetic Ointment | 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 | Minimal | 24 participants |
| Compounded Topical Anesthetic Ointment | 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 | No response | 0 participants |
| Compounded Topical Anesthetic Ointment | 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 | Mild | 15 participants |
Secondary
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
Time frame: Baseline to two days after injection of Restylane® into the nasolabial folds
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pliaglis® Cream | Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds | 0 participants |
| Compounded Topical Anesthetic Ointment | Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds | 0 participants |
Secondary
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?
Time frame: Day of injection of Restylane® into the nasolabial folds
Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pliaglis® Cream | 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 | Yes | 44 participants |
| Pliaglis® Cream | 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 | No | 7 participants |
| Compounded Topical Anesthetic Ointment | 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 | Yes | 44 participants |
| Compounded Topical Anesthetic Ointment | 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 | No | 7 participants |