Aging, Pain
Conditions
Keywords
wrinkles, dermal filler, collagen, soft tissue augmentation, lidocaine, aesthetic
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.
Interventions
Sponsors
Weinkle, Susan H., M.D.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Immediate Post-injection Pain Severity by Subject | immediate post-injection | 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). |
| Assessment of Immediate Post-injection Pain Severity by Investigator | immediate post injection | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pain Assessment Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Pain Assessment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 63.2 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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
Time frame: immediate post injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Assessment for Evolence/Topical Anesthetic | Assessment of Immediate Post-injection Pain Severity by Investigator | 5.2 units on a scale | Standard Deviation 2.1 |
| Pain Assessment for Evolence/Lidocaine | Assessment of Immediate Post-injection Pain Severity by Investigator | 2.0 units on a scale | Standard Deviation 0.8 |
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).
Time frame: immediate post-injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Assessment for Evolence/Topical Anesthetic | Assessment of Immediate Post-injection Pain Severity by Subject | 6.3 units on a scale | Standard Deviation 2 |
| Pain Assessment for Evolence/Lidocaine | Assessment of Immediate Post-injection Pain Severity by Subject | 2.0 units on a scale | Standard Deviation 1 |