Trial Outcomes & Findings for Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections (NCT NCT00716443)

NCT ID: NCT00716443

Last Updated: 2022-08-23

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds
• Results posted on: 2022-08-23

Participant Flow

Dates of recruitment period: First subject was enrolled on July 30, 2008 and the last subject was enrolled on September 8, 2008.

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.

Participant milestones

Measure	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.
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pliaglis® Cream and Compounded Topical Anesthetic Ointment n=51 Participants 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.
Age, Continuous	47.8 years STANDARD_DEVIATION 8.34 • n=93 Participants
Sex: Female, Male Female	50 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 Participants 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	2.3 centimeters Standard Deviation 2.07	2.8 centimeters Standard Deviation 2.17
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	2.8 centimeters Standard Deviation 2.22
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	0.6 centimeters Standard Deviation 0.93
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	0.5 centimeters Standard Deviation 0.91

SECONDARY outcome

Timeframe: three hours after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	4 participants	2 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 Minimal	23 participants	24 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 Mild	15 participants	15 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 Moderate	8 participants	9 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 Severe	1 participants	1 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 No response	0 participants	0 participants

SECONDARY outcome

Timeframe: three hours after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	10 participants	8 participants
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	29 participants
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	13 participants
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	1 participants

SECONDARY outcome

Timeframe: three hours after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	10 participants	9 participants
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	14 participants
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	28 participants

SECONDARY outcome

Timeframe: three hours after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	13 participants	12 participants
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	39 participants
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	0 participants

SECONDARY outcome

Timeframe: Upon first needle stick of injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	17 participants	13 participants
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	25 participants
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	12 participants
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	1 participants

SECONDARY outcome

Timeframe: immediately after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	35 participants	29 participants
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	15 participants
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	7 participants
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	0 participants

SECONDARY outcome

Timeframe: one hour after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	49 participants
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	2 participants
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	0 participants
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	0 participants

SECONDARY outcome

Timeframe: three hours after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	50 participants	49 participants
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	2 participants
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	0 participants
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	0 participants

SECONDARY outcome

Timeframe: upon first needle stick of injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	14 participants	9 participants
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	29 participants
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	13 participants
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	0 participants

SECONDARY outcome

Timeframe: immediately after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	35 participants	28 participants
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	18 participants
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	4 participants
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	1 participants

SECONDARY outcome

Timeframe: one hour after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	0 participants
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	49 participants
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	2 participants
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	0 participants

SECONDARY outcome

Timeframe: three hours after injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	50 participants
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	1 participants
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	0 participants
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	0 participants

SECONDARY outcome

Timeframe: Day of injection of Restylane® into the nasolabial folds

Population: ITT (Intent to Treat), LOCF (Last Observation Carried Forward)

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?"

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	44 participants
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	7 participants

SECONDARY outcome

Timeframe: Baseline to two days after injection of Restylane® into the nasolabial folds

Population: Safety

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

Outcome measures

Measure	Pliaglis® Cream n=51 Participants Pliaglis® Cream	Compounded Topical Anesthetic Ointment n=51 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	0 participants

Adverse Events

Pliaglis® Cream and Compounded Topical Anesthetic Ointment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Pliaglis® Cream and Compounded Topical Anesthetic Ointment n=51 participants at risk 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.

General disorders Implant site bruising

5.9% 3/51 • Number of events 3 • 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.

Additional Information

Ron W. Gottschalk, MD / Medical Director

Galderma Laboratories, L.P.

Phone: 817-961-5358

Email: ron.gottschalk@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER