Trial · NCT00716443
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
NCT00716443, Phase 4, Terminated, Galderma R&D; results first posted 2010-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections. Trials, record NCT00716443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00716443
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
- NCT number
- NCT00716443
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 51 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Nasolabial Folds
- Interventions
- tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream), benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
- First posted
- 2008-07-16
- Last updated
- 2022-08-23
- Results first posted
- 2010-02-01
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 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) | centimeters | MEAN |
| 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 | three hours after injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| 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 | three hours after injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| 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 | three hours after injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| 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 | three hours after injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| 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 | Upon first needle stick of injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| 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 | immediately after injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| 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 | one hour after injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| 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 | three hours after injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
| 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 | upon first needle stick of injection of Restylane® into the nasolabial folds | ITT (Intent to Treat), LOCF (Last Observation Carried Forward) | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Pliaglis® Cream | upon first needle stick | 2.3 | Standard Deviation 2.07 | centimeters |
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 | Compounded Topical Anesthetic Ointment | upon first needle stick | 2.8 | Standard Deviation 2.17 | centimeters |
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 | Pliaglis® Cream | immediately after injection | 2.7 | Standard Deviation 2.14 | centimeters |
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 | Compounded Topical Anesthetic Ointment | immediately after injection | 2.8 | Standard Deviation 2.22 | centimeters |
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 | Pliaglis® Cream | one hour after injection | 0.8 | Standard Deviation 1.12 | centimeters |
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 | Compounded Topical Anesthetic Ointment | one hour after injection | 0.6 | Standard Deviation 0.93 | centimeters |
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 | Pliaglis® Cream | three hours after injection | 0.5 | Standard Deviation 1.14 | centimeters |
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 | Compounded Topical Anesthetic Ointment | three hours after injection | 0.5 | Standard Deviation 0.91 | centimeters |
| 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 | Pliaglis® Cream | None | 4 | participants | |
| 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 | Compounded Topical Anesthetic Ointment | None | 2 | participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pliaglis® Cream and Compounded Topical Anesthetic Ointment | 51 | |
| Overall Study | COMPLETED | Pliaglis® Cream and Compounded Topical Anesthetic Ointment | 51 | |
| Overall Study | NOT COMPLETED | Pliaglis® Cream and Compounded Topical Anesthetic Ointment | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Implant site bruising | General disorders | Pliaglis® Cream and Compounded Topical Anesthetic Ointment | 3 | 51 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pliaglis® Cream and Compounded Topical Anesthetic Ointment | ||
| Total, other adverse events | Pliaglis® Cream and Compounded Topical Anesthetic Ointment | 3 | 51 |
| Total, serious adverse events | Pliaglis® Cream and Compounded Topical Anesthetic Ointment | 0 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Pliaglis® Cream vs 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 |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00716443
GET https://conductscience.org/api/trials/v1/NCT00716443/results?page=2