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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weinkle, Susan H., M.D.
ClinicalTrials.gov Identifier:
NCT00929071
First received: June 24, 2009
Last updated: August 4, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Weinkle, Susan H., M.D.
ClinicalTrials.gov Identifier: NCT00929071     History of Changes
Other Study ID Numbers: IIS DP101L - US - 02
Study First Received: June 24, 2009
Results First Received: December 16, 2013
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 27, 2014