Pain PerceptionPhase 2/3FASTNCT01145326
Functional Microarray Augmentation of Skin Treatment With Lidocaine
A Phase 2/3 study testing Microneedle-facilitated lidocaine application in people with Pain Perception and Phlebotomy, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Perception, Phlebotomy
- What is being tested?
- Microneedle-facilitated lidocaine application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: age at least 18 years, must provide voluntary consent, weight at least 50 kg, no allergies to lidocaine, no skin disease, inflammation, or infection at the venipuncture sites to be tested
Exclusion Criteria: cannot have any major dermatologic disease history, known liver abnormalities, women who are currently breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Schusterman Clinic
Tulsa, Oklahoma, 74135
About this study
Official title: Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST Lidocaine)
The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.
Read the detailed description
The study's primary goal is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided by lidocaine gel 4% (LG4). A secondary goal is to determine whether the depth of anesthesia is enhanced.
- Conditions
- Pain Perception, Phlebotomy
- Being tested
- 4% lidocaine gel application with sham microneedle device, Microneedle-facilitated lidocaine application
- Keywords
- venipuncture, phlebotomy, pain perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% lidocaine gel application with sham microneedle deviceDrug
Also called 4% Lidocaine gel with sham-functional microarray (FMA)
Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).
Microneedle-facilitated lidocaine applicationDrug
Also called 4% lidocaine gel with functional microarray
Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement. Receives: Drug: 4% lidocaine gel application with sham microneedle device |
| Microneedle | Experimental | Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement. Receives: Drug: Microneedle-facilitated lidocaine application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venipuncture pain levels
Measured: 1 hour
Secondary outcomes (1)
Undesirable side effects
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: The device is undergoing further study in China, per FDA requirements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain PerceptionStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen H. Thomas, MD MPH, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145326
- Sponsor's protocol ID
- OUDEM 2010-1
- Acronym
- FAST
- Status last verified
- Mar 2017
- First submitted
- 14 Jun 2010
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST Lidocaine)
- ClinicalTrials.gov ID
- NCT01145326
- Acronym / sponsor ID
- FAST / OUDEM 2010-1
- Conditions
- Pain Perception, Phlebotomy
- Keywords
- venipuncture, phlebotomy, pain perception
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The device is undergoing further study in China, per FDA requirements.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Jun 2010 (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.
The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.
Detailed description
The study's primary goal is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided by lidocaine gel 4% (LG4). A secondary goal is to determine whether the depth of anesthesia is enhanced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Drug: 4% lidocaine gel application with sham microneedle deviceSham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement. |
| Microneedle | Experimental | Drug: Microneedle-facilitated lidocaine applicationFunctional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 4% lidocaine gel application with sham microneedle deviceAlso: 4% Lidocaine gel with sham-functional microarray (FMA)Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA). | Drug | Control |
| Microneedle-facilitated lidocaine applicationAlso: 4% lidocaine gel with functional microarrayApplication of 4% lidocaine gel (LG4), after application of microneedle (FMA) device | Drug | Microneedle |
Primary outcome
Venipuncture pain levels
Time frame: 1 hour
1 secondary outcome
Undesirable side effects
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
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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.
Stephen H. Thomas, MD MPH principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Microneedle-facilitated lidocaine application in people with Pain Perception and Phlebotomy, run by University of Oklahoma 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?
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: withdrawn, as of the sponsor's last update on 16 Mar 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Venipuncture pain levels (time frame: 1 hour). 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 16 Mar 2017.