AgingAD-1016NCT00929071
Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®
A study testing Evolence, Lidocaine and topical anesthetic in people with Aging and Pain, run by Weinkle, Susan H., M.D. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Evolence, Lidocaine and topical anesthetic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Susan Weinkle, Private Practice
Bradenton, Florida, 34209
About this study
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).
Read the 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.
- Being tested
- Evolence, Lidocaine, topical anesthetic
- Keywords
- wrinkles, dermal filler, collagen, soft tissue augmentation, lidocaine, aesthetic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolenceDevice
Also called collagen, Dermicol-P35 27G
Injectable collagen
LidocaineDevice
admix anesthetic
topical anestheticDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: Evolence; Drug: topical anesthetic |
| 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. Receives: Device: Evolence; Device: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: immediate post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weinkle, Susan H., M.D.
- Responsible party
- Sponsor
- Investigators
- Susan Weinkle, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929071
- Sponsor's protocol ID
- IIS DP101L - US - 02
- Acronym
- AD-1016
- Status last verified
- Aug 2014
- First submitted
- 24 Jun 2009
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®
- ClinicalTrials.gov ID
- NCT00929071
- Acronym / sponsor ID
- AD-1016 / IIS DP101L - US - 02
- Keywords
- wrinkles, dermal filler, collagen, soft tissue augmentation, lidocaine, aesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Weinkle, Susan H., M.D.
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 11 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain assessment for Evolence/topical anesthetic | Experimental | Device: Evolence, Drug: topical anestheticAssess 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 | Device: Evolence, Device: LidocaineAssess 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolenceAlso: collagen, Dermicol-P35 27GInjectable collagen | Device | Pain assessment for Evolence/Lidocaine, Pain assessment for Evolence/topical anesthetic |
| Lidocaineadmix anesthetic | Device | Pain assessment for Evolence/Lidocaine |
| topical anesthetic | Drug | Pain assessment for Evolence/topical anesthetic |
Primary outcome
Assessment of Immediate Post-injection Pain Severity by Subject
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Weinkle, MD principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evolence, Lidocaine and topical anesthetic in people with Aging and Pain, run by Weinkle, Susan H., M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Immediate Post-injection Pain Severity by Subject (time frame: immediate post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.