Healthy VolunteersPhase 4NCT01545765

Anesthetic Effect Duration Assessment

A Phase 4 study testing Lidocaine 7% + Tetracaine 7% cream in people with Healthy Volunteers, run by Galderma R&D at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Lidocaine 7% + Tetracaine 7% cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: May 2012to May 2012
Phase: Phase 4
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,

Who cannot join

Female subjects who are pregnant or breast-feeding; or plan to become pregnant,
Subjects who have a known allergy to one of the components of the test drug lidocaine, tetracaine or other local anesthetics,
Subjects who are at risk in terms of precautions, warnings, and contra-indication with the study product.

Trial locations and contacts

1 site in 1 country.

United States1 site

Galderma Investigational center
Rochelle Park, New Jersey

Other trials in United States

About this study

Official title: Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas

The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.

Read the detailed description

Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to the randomization. After the completion of the application process, study drug on both sides of the face and on both anterior thighs will be removed by peeling.

After drug removal, the duration of anesthetic effect of the study drug will be tested using a pinprick test. Five (5) pinpricks using a 21-gauge needle will be performed at the 4 target zones (each side of the face and both anterior thighs). The pinprick test will be repeated up to 8 hours after drug removal. There will be a total of 20 post drug removal pinprick test completed.

Conditions: Healthy Volunteers
Being tested: Lidocaine 7% + Tetracaine 7% cream
Keywords: Healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidocaine 7% + Tetracaine 7% creamDrug
Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.

Study groups in NCT01545765
Study group	Role	What they receive
lidocaine 7% and tetracaine 7%	Experimental	Not described Receives: Drug: Lidocaine 7% + Tetracaine 7% cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Anesthesia(Minutes)
Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).
Measured: From T0 (product removal) up to T8 hours after product removal

Secondary outcomes (1)

Adverse Events
Incidence of adverse events was to be reported during the study period
Measured: During the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012May 2012

First posted7 Mar 2012 (estimated)
Study startMay 2012
Primary completionMay 2012
Study completionMay 2012

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 Healthy VolunteersStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01545765
Sponsor's protocol ID: RD.03.SPR.29103
Status last verified: Jun 2013
First submitted: 24 Feb 2012
Last updated: 2 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas
ClinicalTrials.gov ID: NCT01545765
Acronym / sponsor ID: RD.03.SPR.29103
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 7 Mar 2012 (estimated)
Results: Posted 4 Sep 2013

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 evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
lidocaine 7% and tetracaine 7%	Experimental	Drug: Lidocaine 7% + Tetracaine 7% cream

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,

Key exclusion criteria (3 listed)

Female subjects who are pregnant or breast-feeding; or plan to become pregnant,
Subjects who have a known allergy to one of the components of the test drug lidocaine, tetracaine or other local anesthetics,
Subjects who are at risk in terms of precautions, warnings, and contra-indication with the study product.

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
Lidocaine 7% + Tetracaine 7% creamStudy drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.	Drug	lidocaine 7% and tetracaine 7%

Primary outcome

Duration of Anesthesia(Minutes)
Time frame: From T0 (product removal) up to T8 hours after product removal
Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).

1 secondary outcome

Adverse Events
Time frame: During the study

Results and safety

Results posted to the registry on 4 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Face 2 Application Times/ Thight 2 Application Times	31	31

Primary outcome: Duration of Anesthesia(Minutes)

Time frame: From T0 (product removal) up to T8 hours after product removal. Median (Full Range). Unit: Minutes

Measure	Lidocaine 7% + Tetracaine 7% Face - First Application Time n = 31	Lidocaine 7% + Tetracaine 7% Face - Second Application Time n = 31	Lidocaine 7% + Tetracaine 7% Thigh - First Application Time n = 31	Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time n = 31
Value	80 (0 to 420)	140 (0 to 480)	0 (0 to 460)	400 (0 to 480)

Population analysed: A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All study period (from Baseline to end of teh study). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lidocaine 7% + Tetracaine 7%	0 of 31 (0%)	2 of 31 (6.5%)	Not reported

Limitations and caveats (from the sponsor): No limitation or caveat on this study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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.

Regina YAVEL, MD- Dermatologist principal investigator

Galderma investigational center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine 7% + Tetracaine 7% cream in people with Healthy Volunteers, run by Galderma R&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 1 inclusion and 3 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 2 Sep 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2013). 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?

Duration of Anesthesia(Minutes) (time frame: From T0 (product removal) up to T8 hours after product removal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01545765.

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 2 Sep 2021.