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

NCT00716443 | Terminated Phase 4 Results

• 1 other identifier: US10098
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Nasolabial Folds

Keywords

Nasolabial folds; wrinkles; topical anesthetic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• 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 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

  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

  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

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

Study Arms (2)

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.

Drug: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream); Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment

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.

Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment

Interventions

tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream) DRUG

Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections

Also known as: Pliaglis® Cream

Pliaglis® Cream

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

Also known as: BLT ointment

Pliaglis® Cream; benzocaine 20% / lidocaine 6% / tetracaine 4% ointment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (4)

Skin and Cancer Associates, Center for Cosmetic Enhancement

Aventura, Florida, 33180, United States

Location

Palm Beach Esthetic Dermatology and Laser Center

West Palm Beach, Florida, 33401, United States

Location

Sadick Dermatology

New York, New York, 10021, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Interventions

Tetracaine; Lidocaine; Benzocaine; Ointments

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Ron W. Gottschalk, MD / Medical Director
• Organization: Galderma Laboratories, L.P.

ron.gottschalk@galderma.com

817-961-5358

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 23, 2022
• Results First Posted: February 1, 2010

Record last verified: 2012-09

Locations

US (4)