HealthyPhase 1NCT01688518
Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers
A Phase 1 study testing Heated Lidocaine/Tetracaine Patch and 5% Lidocaine Patch in people with Healthy, run by CRI Lifetree at 1 site in United States.
Trial summary
This will be a randomized, single-blind, active-controlled, two-period crossover study in adult volunteers to compare the duration and depth of anesthesia between Synera® and Lidoderm® patches when applied for 30 minutes and 4 hours. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Heated Lidocaine/Tetracaine Patch and 5% Lidocaine Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female 18-60 years of age, inclusive.
- Subject is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, clinical laboratory profile, and 12-lead electrocardiogram (ECG).
- Subject is willing to refrain from using any local topical preparations on the volar aspect of the forearms for 24 hours prior to each site visit.
- Subject has normal, intact skin bilaterally at the antecubital area.
- If female, must be of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):
- Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
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- A vasectomized partner,
- Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to test product administration,
- Intrauterine device (IUD), or
- Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
- If female, must have a negative urine pregnancy test at Screening and at check-in of each Treatment Period.
- Subject is willing to be blindfolded during the study and agrees to abide by all study restrictions and comply with all study procedures.
- Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
Who cannot join
- Subject has clinically significant ECG abnormalities at screening.
- Subject is currently receiving class I, II, or III anti-arrhythmic agents.
- Subject has used over-the-counter (OTC) or prescription analgesics within 24 hours prior to either study period.
- Subject has a known allergy or history of significant adverse reaction to any component of the treatment or related compounds.
- Subject has a history of or active use or abuse of illicit drug substance or alcohol abuse.
- Subject has a positive urine test result for drugs of abuse or a positive ethanol breath test at the Screening Visit or check-in to Treatment Visit 1.
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- Subject has active dermatological disease of any origin that may interfere with the ability to participate.
- Subject has denuded or broken skin on either forearm.
- Subject has a history of unstable peripheral/vascular disease and/or hypertensive vascular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lifetree Clinical Research
Salt Lake City, Utah, 84106
About this study
This will be a randomized, single-blind, active-controlled, two-period crossover study in adult volunteers to compare the duration and depth of anesthesia between Synera® and Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening Visit, two Treatment Periods, and a Follow-Up Phone Contact.
- Conditions
- Healthy
- Being tested
- Heated Lidocaine/Tetracaine Patch, 5% Lidocaine Patch
- Keywords
- Evaluation, Depth and Duration, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated Lidocaine/Tetracaine PatchDrug
Also called Synera® Patch
5% Lidocaine PatchDrug
Also called Lidoderm® Patch
| Study group | Role | What they receive |
|---|---|---|
| Synera® for 30min & Lidoderm® for 4 hours | Active comparator | Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period. Receives: Drug: Heated Lidocaine/Tetracaine Patch; Drug: 5% Lidocaine Patch |
| Lidoderm® for 30min & Synera® for 4 hours | Active comparator | Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period. Receives: Drug: Heated Lidocaine/Tetracaine Patch; Drug: 5% Lidocaine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.
Measured: Approximately 5 months
Secondary outcomes (1)
Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.
Measured: Approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- CRI Lifetree
- Sponsor type
- University, hospital or other
- Collaborators
- Nuvo Research Inc.
- Responsible party
- Sponsor
- Investigators
- Miroslav Backonja, MD, Principal investigator, CRI Lifetree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688518
- Sponsor's protocol ID
- LCR-07-01-101
- Status last verified
- Jan 2013
- First submitted
- 17 Sep 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01688518
- Acronym / sponsor ID
- LCR-07-01-101
- Conditions
- Healthy
- Keywords
- Evaluation, Depth and Duration, Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CRI LifetreeUniversity, hospital or other
- Collaborators
- Nuvo Research Inc.
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, single-blind, active-controlled, two-period crossover study in adult volunteers to compare the duration and depth of anesthesia between Synera® and Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening Visit, two Treatment Periods, and a Follow-Up Phone Contact.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synera® for 30min & Lidoderm® for 4 hours | Active comparator | Drug: Heated Lidocaine/Tetracaine Patch, Drug: 5% Lidocaine PatchHeated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period. |
| Lidoderm® for 30min & Synera® for 4 hours | Active comparator | Drug: Heated Lidocaine/Tetracaine Patch, Drug: 5% Lidocaine PatchHeated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject is male or female 18-60 years of age, inclusive.
- Subject is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, clinical laboratory profile, and 12-lead electrocardiogram (ECG).
- Subject is willing to refrain from using any local topical preparations on the volar aspect of the forearms for 24 hours prior to each site visit.
- Subject has normal, intact skin bilaterally at the antecubital area.
- If female, must be of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):
Key exclusion criteria (9 listed)
- Subject has clinically significant ECG abnormalities at screening.
- Subject is currently receiving class I, II, or III anti-arrhythmic agents.
- Subject has used over-the-counter (OTC) or prescription analgesics within 24 hours prior to either study period.
- Subject has a known allergy or history of significant adverse reaction to any component of the treatment or related compounds.
- Subject has a history of or active use or abuse of illicit drug substance or alcohol abuse.
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 |
|---|---|---|
| Heated Lidocaine/Tetracaine PatchAlso: Synera® Patch | Drug | Lidoderm® for 30min & Synera® for 4 hours, Synera® for 30min & Lidoderm® for 4 hours |
| 5% Lidocaine PatchAlso: Lidoderm® Patch | Drug | Lidoderm® for 30min & Synera® for 4 hours, Synera® for 30min & Lidoderm® for 4 hours |
Primary outcome
Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.
Time frame: Approximately 5 months
1 secondary outcome
Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.
Time frame: Approximately 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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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.
Miroslav Backonja, MD principal investigator
CRI Lifetree
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Heated Lidocaine/Tetracaine Patch and 5% Lidocaine Patch in people with Healthy, run by CRI Lifetree 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 13 inclusion and 9 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 4 Jan 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin. (time frame: Approximately 5 months). 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 4 Jan 2013.