NCT02379221

Brief Summary

The purpose of the study is to compare two modalities of local anesthetic administration prior to the placement of cosmetic facial injectable fillers. Both short and long term pain perceptions for the facial filler procedure will be compared in patients receiving 4% Topicaine gel on half their face, and 20% benzocaine gel prior to 2% lidocaine 1:100k epinephrine nerve block injections on the other half of their face. The objective is to quantify the subjective pain experienced by these two modalities of local anesthetic during the procedure of Juvederm XC filler injections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 24, 2018

Completed
Last Updated

April 29, 2020

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

February 27, 2015

Results QC Date

December 6, 2016

Last Update Submit

April 16, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Participants Anesthetic Preference

    Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.

    one week post treatment

Secondary Outcomes (5)

  • Mean Pain Level Associated With the Local Anesthetic Injection

    5-10 minutes post-procedure

  • Mean Pain Level Associated With the Local Topical Anesthetic

    5-10 min post procedure

  • Mean Pain Level Associated With Facial Filler Injection at the Upper Lip

    5-10 minutes post procedure

  • Mean Pain Level Associated With Facial Filler Injection to the Lower Lip

    5-10 minutes post procedure

  • Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold

    5-10 minutes post procedure

Study Arms (1)

Injectable / Topical

EXPERIMENTAL

Half of the face is injected with local anesthesia (lidocaine-epinephrine), the other half is treated with topical anesthesia (topicaine gel) per randomize method.

Drug: InjectableDrug: Topical

Interventions

InjectableDRUG

20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection

Also known as: benzocaine gel-lidocaine-epinephrine nerve block injection
Injectable / Topical
TopicalDRUG

4% Topicaine gel

Also known as: topical anesthesia
Injectable / Topical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Patients with deepened labiomental folds or decreased lip volume and architecture who are scheduled to receive Juvederm XC injections in DGMC Oral \& Maxillofacial Surgery clinic.

You may not qualify if:

  • Pregnant or nursing
  • History of any type of neuralgia or paresthesia, or paresis
  • Allergy or contraindication to lidocaine or hyaluronic acid
  • Use of hyaluronic acid in last 6 months
  • Previous reaction to Juvederm or other hyaluronic acid based fillers
  • Have an active inflammatory or infectious process at the injection site.
  • Use of monoamine oxidase (MAO) inhibitors or tricyclic antidepressants
  • Severe coronary artery disease
  • Diagnosis of any cardiac dysrhythmia with an ECG finding other than normal sinus rhythm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USAF David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Related Publications (8)

  • Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.

    PMID: 19735519BACKGROUND

  • Levy PM, De Boulle K, Raspaldo H. A split-face comparison of a new hyaluronic acid facial filler containing pre-incorporated lidocaine versus a standard hyaluronic acid facial filler in the treatment of naso-labial folds. J Cosmet Laser Ther. 2009 Sep;11(3):169-73. doi: 10.1080/14764170902833142.

    PMID: 19337944BACKGROUND

  • Levy PM, De Boulle K, Raspaldo H. Comparison of injection comfort of a new category of cohesive hyaluronic acid filler with preincorporated lidocaine and a hyaluronic acid filler alone. Dermatol Surg. 2009 Feb;35 Suppl 1:332-6; discussion 337. doi: 10.1111/j.1524-4725.2008.01045.x.

    PMID: 19207322BACKGROUND

  • Smith KC, Melnychuk M. Five percent lidocaine cream applied simultaneously to the skin and mucosa of the lips creates excellent anesthesia for filler injections. Dermatol Surg. 2005 Nov;31(11 Pt 2):1635-7. doi: 10.2310/6350.2005.31253.

    PMID: 16416650BACKGROUND

  • Lopez-Jornet P, Camacho-Alonso F, Martinez-Canovas A. Clinical evaluation of polyvinylpyrrolidone sodium hyaluronate gel and 0.2% chlorhexidine gel for pain after oral mucosa biopsy: a preliminary study. J Oral Maxillofac Surg. 2010 Sep;68(9):2159-63. doi: 10.1016/j.joms.2009.09.047. Epub 2010 Jun 11.

    PMID: 20538398BACKGROUND

  • Kim YK, Kim SG, Kim JH. Altered sensation after orthognathic surgery. J Oral Maxillofac Surg. 2011 Mar;69(3):893-8. doi: 10.1016/j.joms.2010.10.025. Epub 2011 Jan 6.

    PMID: 21211888BACKGROUND

  • Maria A, Malik M, Virang P. Comparison of primary and secondary closure of the surgical wound after removal of impacted mandibular third molars. J Maxillofac Oral Surg. 2012 Sep;11(3):276-83. doi: 10.1007/s12663-011-0287-9. Epub 2011 Sep 23.

    PMID: 23997477BACKGROUND

  • Brajkovic D, Brkovic B, Milic M, Biocanin V, Krsljak E, Stojic D. Levobupivacaine vs. bupivacaine for third molar surgery: quality of anaesthesia, postoperative analgesia and local vascular effects. Clin Oral Investig. 2014;18(5):1481-8. doi: 10.1007/s00784-013-1114-0. Epub 2013 Oct 6.

    PMID: 24097340BACKGROUND

MeSH Terms

Interventions

InjectionsAnesthesia

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsAnesthesia and Analgesia

Results Point of Contact

Title
Dr. Jason May
Organization
Travis AFB OMFS Clinic
jason.may.11@us.af.mil
707-423-7085

Study Officials

  • Ryan Diepenbrock, DDS

    USAF David Grant Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Study Start

September 1, 2014

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

April 29, 2020

Results First Posted

October 24, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)