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

Pain Clinical Trial

— AD-1016  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929071
• Other study ID #: IIS DP101L - US - 02
• Status: Completed
• Phase: N/A
• First received: June 24, 2009
• Last updated: August 4, 2014
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: August 2014
• Source: Weinkle, Susan H., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Pain

Intervention

Device:
• Evolence
Injectable collagen
• Lidocaine
admix anesthetic

Drug:
• topical anesthetic

Locations

Country	Name	City	State
United States	Susan Weinkle, Private Practice	Bradenton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Weinkle, Susan H., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No