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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain assessment for Evolence/topical anesthetic | Experimental | 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 . |
|
| Pain assessment for Evolence/Lidocaine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolence | Device | Injectable collagen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Weinkle, MD | Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Susan Weinkle, Private Practice | Bradenton | Florida | 34209 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Assess a difference in immediate post-injection pain of Evolence/topical anesthetic at the left nasolabial fold vs Evolence/Lidocaine at the right nasolabial fold. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pain Assessment | Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | immediate post-injection | nasolabial folds | Participants |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pain Assessment | Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan H. Weinkle, MD | Susan H. Weinkle, MD | 941-794-5432 | sweinkle@aol.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Lidocaine | Device | admix anesthetic |
|
| topical anesthetic | Drug |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | immediate post injection | nasolabial folds | Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
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| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |