We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE® (AD-1016)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929071
First Posted: June 26, 2009
Last Update Posted: August 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weinkle, Susan H., M.D.
  Purpose

The study doctor will give EVOLENCE® mixed with Lidocaine to people in this study to see if it effectively reduces pain while injecting and works to correct nasolabial wrinkles.

The product being used in this study is EVOLENCE®, which is currently marketed in the United States for the cosmetic correction of soft tissue contour deficiencies (including wrinkles), and been approved by the U.S. Food and Drug Administration (FDA).


Condition Intervention
Aging Pain Device: Evolence Device: Lidocaine Drug: topical anesthetic

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®

Resource links provided by NLM:


Further study details as provided by Weinkle, Susan H., M.D.:

Primary Outcome Measures:
  • Assessment of Immediate Post-injection Pain Severity by Subject [ Time Frame: immediate post-injection ]
    Subjects assessment of immediate post-injection pain severity using a visual analogue scale (VAS) 100 mm in length, ranging from no pain (0) to unbearable pain (100).

  • Assessment of Immediate Post-injection Pain Severity by Investigator [ Time Frame: immediate post injection ]
    Investigators assessment of immediate post-injection pain severity using Thermometer Pain Scale (TPS) with a range of 0-10 where 0=no pain and 10=worst possible pain


Enrollment: 10
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain assessment for Evolence/topical anesthetic
Assess injection pain severity for a one time 1.0 mL injection of Evolence with 0.2 ml of topical anesthetic, applied 30 minutes prior to injection, to the left nasolabial fold of each participant .
Device: Evolence
Injectable collagen
Other Names:
  • collagen
  • Dermicol-P35 27G
Drug: topical anesthetic
Experimental: Pain assessment for Evolence/Lidocaine
Assess injection pain severity for a one time 1.0 mL injection of Evolence mixed with 0.18 mL of 2% lidocaine (0.3% final lidocaine-HCl) in the right nasolabial fold of each participant.
Device: Evolence
Injectable collagen
Other Names:
  • collagen
  • Dermicol-P35 27G
Device: Lidocaine
admix anesthetic

Detailed Description:
The aim of this study is to determine if the admixture of lidocaine can effectively be used to mediate pain relief during the injection of EVOLENCE® while achieving cosmetic correction.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understanding and voluntary signature (including date) of an informed consent document
  • Healthy male or female > 18 years of age
  • Clinical evidence of bilateral, fully visible aging defects in the nasolabial area with grades 2.0, 2.5, or 3.0 on the Modified Fitzpatrick Wrinkle Scale (MFWS section 6.5)
  • Willingness to receive EVOLENCE® injections in areas of aging defects (wrinkles)
  • Willingness and ability to comply with the requirements of this protocol

Exclusion Criteria:

  • History of multiple severe allergies (food, drug, or substances) and/or anaphylactic shock
  • Subjects with a history of a bleeding disorder, or receiving chronic anti-platelet therapy or other chronic anticoagulant medication
  • Subject on low-dose aspirin therapy or a non-steroidal anti-inflammatory drug, not interrupted at least 10 days prior to injection and/or resumed within 1 week after injection
  • History of allergies and/or sensitivity to porcine, bovine and human collagen, lidocaine, local anesthetics products or natural rubber latex
  • Autoimmune or collagen vascular disease, or connective tissue disease
  • Active skin disease, inflammation or related condition such as infection, psoriasis and herpes zoster near or on the nasolabial folds area at study entry and/or within 6 months prior to study entry
  • Previous tissue augmentation - permanent implants or hyaluronic acid within 6 months or EVOLENCE® within 12 months in the treatment area
  • Currently being treated with immunosuppressive drugs, chemotherapy agents or systemic steroids or has been treated within the last 3 months prior to study entry
  • Botulinum-toxin A within 6 weeks in treatment area
  • Received any investigational products within 30 days prior to the study enrollment
  • Females of Childbearing Potential
  • Any clinically significant organic disease or other medical condition that in the opinion of the PI, makes the subject a poor candidate for participation in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929071


Locations
United States, Florida
Susan Weinkle, Private Practice
Bradenton, Florida, United States, 34209
Sponsors and Collaborators
Weinkle, Susan H., M.D.
Investigators
Principal Investigator: Susan Weinkle, MD Private Practice
  More Information

Responsible Party: Weinkle, Susan H., M.D.
ClinicalTrials.gov Identifier: NCT00929071     History of Changes
Other Study ID Numbers: IIS DP101L - US - 02
First Submitted: June 24, 2009
First Posted: June 26, 2009
Results First Submitted: December 16, 2013
Results First Posted: July 11, 2014
Last Update Posted: August 7, 2014
Last Verified: August 2014

Keywords provided by Weinkle, Susan H., M.D.:
wrinkles
dermal filler
collagen
soft tissue augmentation
lidocaine
aesthetic

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action