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

NCT00929071 | Completed Results

• 1 other identifier: IIS DP101L - US - 02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Aging; Pain

Keywords

wrinkles; dermal filler; collagen; soft tissue augmentation; lidocaine; aesthetic

Outcome Measures

Primary Outcomes (2)

• Assessment of Immediate Post-injection Pain Severity by Subject

  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).

  immediate post-injection

• Assessment of Immediate Post-injection Pain Severity by Investigator

  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

  immediate post injection

Study Arms (2)

Pain assessment for Evolence/topical anesthetic

EXPERIMENTAL

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; Drug: topical anesthetic

Pain assessment for Evolence/Lidocaine

EXPERIMENTAL

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; Device: Lidocaine

Interventions

Evolence DEVICE

Injectable collagen

Also known as: collagen, Dermicol-P35 27G

Pain assessment for Evolence/Lidocaine; Pain assessment for Evolence/topical anesthetic

Lidocaine DEVICE

admix anesthetic

Pain assessment for Evolence/Lidocaine

topical anesthetic DRUG

Pain assessment for Evolence/topical anesthetic

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weinkle, Susan H., M.D.: lead

Study Sites (1)

Susan Weinkle, Private Practice

Bradenton, Florida, 34209, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Susan H. Weinkle, MD
• Organization: Susan H. Weinkle, MD

sweinkle@aol.com

941-794-5432

Study Officials

• Susan Weinkle, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 26, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 7, 2014
• Results First Posted: July 11, 2014

Record last verified: 2014-08

Locations

US (1)