Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE® (AD-1016)
This study has been completed.
Sponsor:
Weinkle, Susan H., M.D.
Information provided by:
Weinkle, Susan H., M.D.
ClinicalTrials.gov Identifier:
NCT00929071
First received: June 24, 2009
Last updated: June 14, 2011
Last verified: June 2011
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Aging Pain |
Device: collagen |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE® |
Resource links provided by NLM:
Further study details as provided by Weinkle, Susan H., M.D.:
Primary Outcome Measures:
- Severity of injection pain measured by Thermometer Pain Scale. [ Time Frame: Immediate ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain, swelling, bruising, redness [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | January 2009 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pain assessment
Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
|
Device: collagen
Injectable collagen
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 HA 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929071
Locations
| United States, Florida | |
| Susan Weinkle, Private Practice | |
| Bradenton, Florida, United States, 34209 | |
Sponsors and Collaborators
Weinkle, Susan H., M.D.
Investigators
| Principal Investigator: | Susan Weinkle, MD | Private Practice |
More Information
No publications provided
| Responsible Party: | Weinkle, Susan H., M.D., Private Practice |
| ClinicalTrials.gov Identifier: | NCT00929071 History of Changes |
| Other Study ID Numbers: | IIS DP101L - US - 02 |
| Study First Received: | June 24, 2009 |
| Last Updated: | June 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weinkle, Susan H., M.D.:
|
wrinkles dermal filler collagen |
soft tissue augmentation lidocaine aesthetic |
Additional relevant MeSH terms:
|
Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013