Clinical trial NCT00716443: Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nasolabial Folds
Keywords: Nasolabial folds
wrinkles
topical anesthetic
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds
Secondary outcomes:
measure: 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
timeFrame: three hours after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: three hours after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: three hours after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: three hours after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: Upon first needle stick of injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: immediately after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: one hour after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: three hours after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: upon first needle stick of injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: immediately after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: one hour after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: three hours after injection of Restylane® into the nasolabial folds
measure: 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
timeFrame: Day of injection of Restylane® into the nasolabial folds
measure: Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds
timeFrame: Baseline to two days after injection of Restylane® into the nasolabial folds
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Skin and Cancer Associates, Center for Cosmetic Enhancement
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Esthetic Dermatology and Laser Center
state: Florida
city: New York
country: United States
facility: Sadick Dermatology
state: New York
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References: