Clinical trial NCT00929071: Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®
Official title: Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Pain
Keywords: wrinkles
dermal filler
collagen
soft tissue augmentation
lidocaine
aesthetic
Lead sponsor: Weinkle, Susan H., M.D.
Sponsor class: INDIV
First posted: 2009-06-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of Immediate Post-injection Pain Severity by Subject
timeFrame: immediate post-injection
measure: Assessment of Immediate Post-injection Pain Severity by Investigator
timeFrame: immediate post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Susan Weinkle, Private Practice
state: Florida
Study officials:
affiliation: Private Practice
name: Susan Weinkle, MD
role: PRINCIPAL_INVESTIGATOR
References: