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Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pliaglis® Cream | Active Comparator | 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. |
|
| benzocaine 20% / lidocaine 6% / tetracaine 4% ointment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream) | Drug | Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin and Cancer Associates, Center for Cosmetic Enhancement | Aventura | Florida | 33180 | United States | ||
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.
Dates of recruitment period: First subject was enrolled on July 30, 2008 and the last subject was enrolled on September 8, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| benzocaine 20% / lidocaine 6% / tetracaine 4% ointment | Drug | apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections |
|
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| 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 |
| Palm Beach Esthetic Dermatology and Laser Center |
| West Palm Beach |
| Florida |
| 33401 |
| United States |
| Sadick Dermatology | New York | New York | 10021 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Mean | Standard Deviation | centimeters | upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | three hours after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | three hours after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | three hours after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | three hours after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | Upon first needle stick of injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | immediately after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | one hour after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | three hours after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | upon first needle stick of injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | immediately after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | one hour after injection of Restylane® into the nasolabial folds |
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| 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 | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | three hours after injection of Restylane® into the nasolabial folds |
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| 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?" | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | Posted | Number | participants | Day of injection of Restylane® into the nasolabial folds |
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| 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 | Safety | Posted | Number | participants | Baseline to two days after injection of Restylane® into the nasolabial folds |
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Baseline to two days after Restylane® injections
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event9s), if applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 51 | 3 | 51 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site bruising | General disorders | MedDRA Version 10.0 | Systematic Assessment | Bruising is at Restylane® injection site |
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The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron W. Gottschalk, MD / Medical Director | Galderma Laboratories, L.P. | 817-961-5358 | ron.gottschalk@galderma.com |
| ID | Term |
|---|---|
| D013748 | Tetracaine |
| D008012 | Lidocaine |
| D001566 | Benzocaine |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| one hour after injection |
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| three hours after injection |
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