HealthyPhase 1NCT04784728
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure
A Phase 1 study testing Lidocaine topical system 1.8% in people with Healthy, run by Scilex Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions. 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?
- Lidocaine topical system 1.8%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2019to 31 Aug 2019
- 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
- Must be healthy based on medical history, laboratory work, and physical exam
- Body mass index ranging between 18.0-30.0 kg/m2, inclusive
- Capable of unaided swimming
- If childbearing potential, use of acceptable form of birth control
- In case of females of childbearing potential, have a negative serum pregnancy
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 affecting the major body systems, including the skin
- 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)
- Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
- History of addiction, abuse, or misuse of any drug
- Use of nicotine-containing products within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions
The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.
Read the detailed description
In this Phase 1, open-label, three-period crossover study, 24 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments. In each treatment period, the subject will either swim (Treatment A), shower (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 24 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.
- Conditions
- Healthy
- Being tested
- Lidocaine topical system 1.8%
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 ZTlido
lidocaine patch
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine topical system with swimming (Treatment A) | Experimental | One topical system is applied to the mid- to upper-back for 12 hours. Subjects swim for 15 minutes in a heated pool 4 hours after topical system application. Receives: Drug: Lidocaine topical system 1.8% |
| Lidocaine topical system with showering (Treatment B) | Experimental | One topical system is applied to the mid- to upper-back for 12 hours. Subjects take a 10-minute shower 8 hours after topical system application. Receives: Drug: Lidocaine topical system 1.8% |
| Lidocaine topical system under normal conditions (Treatment C) | Experimental | One topical system is applied to the mid- to upper-back for 12 hours. Topical systems are not exposed to water during this period. Receives: Drug: Lidocaine topical system 1.8% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cumulative adhesion score
Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% Adhered (less than half of the patch lifting off the skin), > 0% to < 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The cumulative adhesion score is calculated as the sum of scores at each assessment time point (3, 4.5, 7, 8.5, and 12 hours).
Measured: Over 12 hours
Secondary outcomes (4)
Peak plasma concentration (Cmax) of lidocaine
Peak plasma concentration of lidocaine after product application for 12 hours
Measured: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Area under the plasma concentration-time curve (AUC) from Time 0 to Time 24 hours
Area under the plasma concentration versus time curve from 0 to 24 hours of lidocaine in plasma
Measured: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Area under the plasma concentration-time curve (AUC) from Time 0 to Time Infinity
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
Measured: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Dermal Response Score
Product tolerability is assessed by Dermal Response Score. The application site is evaluated 30 minutes and 2 hours after product removal (12.5 and 14 hours post-dose, respectively). Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test (i.e., application) site.
Measured: 12.5 and 14 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 posted5 Mar 2021
- Study start21 Aug 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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
- Peter Boldingh, PharmD, Principal investigator, AXIS Clinicals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784728
- Sponsor's protocol ID
- SCI-LIDO-ADH-004
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vought K, Greuber E, Patel K, Argoff C, Lissin D. A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects. J Pain Res. 2021 Aug 16;14:2459-2467. doi: 10.2147/JPR.S323789. eCollection 2021.
PubMed 34429646
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions
- ClinicalTrials.gov ID
- NCT04784728
- Acronym / sponsor ID
- SCI-LIDO-ADH-004
- 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
- 21 Aug 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 5 Mar 2021 (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.
The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.
Detailed description
In this Phase 1, open-label, three-period crossover study, 24 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments. In each treatment period, the subject will either swim (Treatment A), shower (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 24 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine topical system with swimming (Treatment A) | Experimental | Drug: Lidocaine topical system 1.8%One topical system is applied to the mid- to upper-back for 12 hours. Subjects swim for 15 minutes in a heated pool 4 hours after topical system application. |
| Lidocaine topical system with showering (Treatment B) | Experimental | Drug: Lidocaine topical system 1.8%One topical system is applied to the mid- to upper-back for 12 hours. Subjects take a 10-minute shower 8 hours after topical system application. |
| Lidocaine topical system under normal conditions (Treatment C) | Experimental | Drug: Lidocaine topical system 1.8%One topical system is applied to the mid- to upper-back for 12 hours. Topical systems are not exposed to water during this period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be healthy based on medical history, laboratory work, and physical exam
- Body mass index ranging between 18.0-30.0 kg/m2, inclusive
- Capable of unaided swimming
- If childbearing potential, use of acceptable form of birth control
- In case of females of childbearing potential, have a negative serum pregnancy
Key exclusion criteria (6 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 affecting the major body systems, including the skin
- 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)
- Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
- History of addiction, abuse, or misuse of any drug
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: ZTlidolidocaine patch | Drug | Lidocaine topical system under normal conditions (Treatment C), Lidocaine topical system with showering (Treatment B), Lidocaine topical system with swimming (Treatment A) |
Primary outcome
Mean cumulative adhesion score
Time frame: Over 12 hours
Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% Adhered (less than half of the patch lifting off the skin), > 0% to < 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The cumulative adhesion score is calculated as the sum of scores at each assessment time point (3, 4.5, 7, 8.5, and 12 hours).
4 secondary outcomes
Peak plasma concentration (Cmax) of lidocaine
Time frame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Area under the plasma concentration-time curve (AUC) from Time 0 to Time 24 hours
Time frame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Area under the plasma concentration-time curve (AUC) from Time 0 to Time Infinity
Time frame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Dermal Response Score
Time frame: 12.5 and 14 hours post-dose
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 5 Mar 2021.
- Derived from this study: PubMed 34429646Vought K, Greuber E, Patel K, Argoff C, Lissin D. A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects. J Pain Res. 2021 Aug 16;14:2459-2467. doi: 10.2147/JPR.S323789. 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.
Peter Boldingh, PharmD 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% 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 5 inclusion and 6 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 5 Mar 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 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 cumulative adhesion score (time frame: Over 12 hours). 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 NCT04784728, 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 5 Mar 2021.