Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®

NCT ID: NCT00929071

Last Updated: 2014-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-02-28

Brief Summary

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).

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.

Conditions

Aging; Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

Evolence

Intervention Type: DEVICE

Injectable collagen

topical anesthetic

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Evolence

Intervention Type: DEVICE

Injectable collagen

Lidocaine

Intervention Type: DEVICE

admix anesthetic

Interventions

Evolence

Injectable collagen

Intervention Type: DEVICE

Lidocaine

admix anesthetic

Intervention Type: DEVICE

topical anesthetic

Intervention Type: DRUG

Other Intervention Names

collagen; Dermicol-P35 27G

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weinkle, Susan H., M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Weinkle, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

Susan Weinkle, Private Practice

Bradenton, Florida, United States

Countries

United States

Other Identifiers

IIS DP101L - US - 02

Identifier Type: -

Identifier Source: org_study_id