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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00716443
First received: July 14, 2008
Last updated: September 21, 2012
Last verified: September 2012

July 14, 2008
September 21, 2012
July 2008
September 2008   (final data collection date for primary outcome measure)
Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds [ Time Frame: upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
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
Subject's Pain Evaluation by VAS scale [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00716443 on ClinicalTrials.gov Archive Site
  • Number of Participants Who Answered the Question "What Level of Pain Did You Experience When You Were Injected?" Three Hours After Injection of Restylane® Into the Nasolabial Folds [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 Who Answered the Question "If You Experienced Pain, Was it What You Expected From the Injection Procedure?" Three Hours After Injection of Restylane® Into the Nasolabial Folds [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: Upon first needle stick of injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: immediately after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: one hour after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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
  • Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds [ Time Frame: upon first needle stick of injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: immediately after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: one hour after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day of injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to two days after injection of Restylane® into the nasolabial folds ] [ Designated as safety issue: Yes ]
    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
  • Subject, Investigator and Blinded Observer questionnaires [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
  • Tolerability assessments, adverse events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
Open-Label, Randomized, Split-Face Study to Evaluate the Efficacy, Safety and Subject Satisfaction of Pain Management During and After Restylane® Dermal Filler Injections for the Correction of Nasolabial Folds

Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Nasolabial Folds
  • Drug: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)
    Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections
    Other Name: Pliaglis® Cream
  • Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
    apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections
    Other Name: BLT ointment
  • Active Comparator: Pliaglis® Cream
    tetracaine 4% / lidocaine 7% cream; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face.
    Interventions:
    • Drug: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)
    • Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
  • Active Comparator: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
    apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face.
    Intervention: Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00716443
US10098
No
Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
Not Provided
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP