HealthyPhase 1NCT04319926
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects
A Phase 1 study testing lidocaine topical system 1.8% and lidocaine patch 5% in people with Healthy, run by Scilex Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5% Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- lidocaine topical system 1.8% and lidocaine patch 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 9 Sep 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be healthy based on by medical history, laboratory work, ECG, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
- Be at least 18 years of age
- If childbearing potential, use of acceptable form of birth control
- In the case of females of childbearing potential, have a negative serum pregnancy test
Who cannot join
- Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
- Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness
- Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
- History of addiction, abuse, and misuse of any drug
- Use of local anesthetics of antiarrhythmic drugs (such as tocainide or mexiletine) within 14 days prior to product application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Two-treatment, Two-period, Single-dose Study Evaluating the Product Adhesion in Healthy, Adult Subjects Using ZTlido 1.8% Topical System and a Generic Lidocaine Patch 5%.
An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%
- Conditions
- Healthy
- Being tested
- lidocaine topical system 1.8%, lidocaine patch 5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine topical system 1.8%Drug
Also called lidocaine patch 1.8%, ZTlido
One topical system is applied to the subject's back for 12 hours.
lidocaine patch 5%Drug
One generic lidocaine patch is applied to the subject's back for 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Patch (Sequence T1T2) | Experimental | Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 1, lidocaine 1.8% topical systems are applied in Period 1, and the generic lidocaine 5% patches are applied in Period 2. Receives: Drug: lidocaine topical system 1.8%; Drug: lidocaine patch 5% |
| Lidocaine Patch (Sequence T2T1) | Experimental | Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 2, generic lidocaine 5% patches are applied in Period 1, and the lidocaine 1.8% topical systems are applied in Period 2. Receives: Drug: lidocaine topical system 1.8%; Drug: lidocaine patch 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Adhesion
Percent adhesion is assessed by laying a transparent sheet the exact size of the product over the top of the product and outlining areas of adhesion with a marker on the transparent sheet. The area excluded from the adhered area will be assessed to determine the degree of lift-off. Adhesion is assessed every 3 hours after product application. Mean percent adhesion is calculated as the sum of scores at each assessment time point divided by the total number of observations.
Measured: 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start7 Sep 2018
- Primary completion9 Sep 2018
- Study completion9 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scilex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Luger, MD, Principal investigator, AXIS Clinicals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319926
- Sponsor's protocol ID
- SCI-LIDO-ADH-003
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2020
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021.
PubMed 33654425
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-treatment, Two-period, Single-dose Study Evaluating the Product Adhesion in Healthy, Adult Subjects Using ZTlido 1.8% Topical System and a Generic Lidocaine Patch 5%.
- ClinicalTrials.gov ID
- NCT04319926
- Acronym / sponsor ID
- SCI-LIDO-ADH-003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Scilex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 9 Sep 2018 (actual)
- Study completion
- 9 Sep 2018 (actual)
- First posted
- 24 Mar 2020 (actual)
- 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.
An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Patch (Sequence T1T2) | Experimental | Drug: lidocaine topical system 1.8%, Drug: lidocaine patch 5%Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 1, lidocaine 1.8% topical systems are applied in Period 1, and the generic lidocaine 5% patches are applied in Period 2. |
| Lidocaine Patch (Sequence T2T1) | Experimental | Drug: lidocaine topical system 1.8%, Drug: lidocaine patch 5%Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 2, generic lidocaine 5% patches are applied in Period 1, and the lidocaine 1.8% topical systems are applied in Period 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be healthy based on by medical history, laboratory work, ECG, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
- Be at least 18 years of age
- If childbearing potential, use of acceptable form of birth control
- In the case of females of childbearing potential, have a negative serum pregnancy test
Key exclusion criteria (5 listed)
- Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
- Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness
- Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
- History of addiction, abuse, and misuse of any drug
- Use of local anesthetics of antiarrhythmic drugs (such as tocainide or mexiletine) within 14 days prior to product application
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 topical system 1.8%Also: lidocaine patch 1.8%, ZTlidoOne topical system is applied to the subject's back for 12 hours. | Drug | Lidocaine Patch (Sequence T1T2), Lidocaine Patch (Sequence T2T1) |
| lidocaine patch 5%One generic lidocaine patch is applied to the subject's back for 12 hours. | Drug | Lidocaine Patch (Sequence T1T2), Lidocaine Patch (Sequence T2T1) |
Primary outcome
Mean Percent Adhesion
Time frame: 12 hours post-dose
Percent adhesion is assessed by laying a transparent sheet the exact size of the product over the top of the product and outlining areas of adhesion with a marker on the transparent sheet. The area excluded from the adhered area will be assessed to determine the degree of lift-off. Adhesion is assessed every 3 hours after product application. Mean percent adhesion is calculated as the sum of scores at each assessment time point divided by the total number of observations.
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 24 Apr 2024.
- Derived from this study: PubMed 33654425Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021.
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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.
Patrick Luger, MD principal investigator
AXIS Clinicals
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 lidocaine topical system 1.8% and lidocaine patch 5% in people with Healthy, run by Scilex Pharmaceuticals, Inc. 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 4 inclusion and 5 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 24 Apr 2024. 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?
Mean Percent Adhesion (time frame: 12 hours post-dose). 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 NCT04319926, which also lists 1 linked publication.
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 24 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.