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

Weinkle, Susan H., M.D.

Status: Completed

Conditions: Aging; Pain

Treatments: Device: Evolence; Drug: topical anesthetic; Device: Lidocaine

Study type: Interventional

Identifiers

NCT00929071

IIS DP101L - US - 02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Pain assessment for Evolence/topical anesthetic

Experimental group

Description:

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 .

Treatment:

Drug: topical anesthetic

Device: Evolence

Pain assessment for Evolence/Lidocaine

Experimental group

Description:

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.

Treatment:

Device: Lidocaine

Device: Evolence