HealthyPhase 1NCT05106400
Clinical Adhesion Study Between ZTlido 1.8% and Three Over-the-counter External Analgesic Lidocaine-containing Patches
A Phase 1 study testing ZTlido (Lidocaine Topical System) 1.8%, Salonpas (Lidocaine Patch 4%) and Aspercreme (Lidocaine Patch 4%) in people with Healthy, run by Scilex Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The study is designed to evaluate and compare the clinical adhesion performance of the ZTlido (Lidocaine Topical System) 1.8% of Scilex Pharmaceuticals Inc. (Reference) versus Salonpas (Lidocaine Patch 4%), Aspercreme (Lidocaine Patch 4%) and IcyHot (Lidocaine 4% + Menthol 1% Patch), on the Mid to upper back while… 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?
- ZTlido (Lidocaine Topical System) 1.8%, Salonpas (Lidocaine Patch 4%) and Aspercreme (Lidocaine Patch 4%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 21 Jul 2021
- 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
- Healthy, male and female subjects aged 18 years and older with a Body Mass Index (BMI) range 18.0-32.49 kg/m2 inclusive (according to the formula of BMI = weight (kg) / [height (m)2]).
- Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 28 days of check-in.
- Subjects whose screening laboratory values are within normal limits or considered by the physician or Principal Investigator to be of no clinical significance.
- Absence of disease markers of HIV 1 \& 2, hepatitis B \& C virus.
- Generally healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
- Generally healthy as documented by 12-lead electrocardiogram (ECG), and clinical laboratory assessments.
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- Any abnormalities/deviations from the acceptable range of medical history, clinical laboratory values, ECG and vitals, that might be considered clinically relevant by the study physician or investigator will be evaluated as individual cases.
- Subjects able to comply with study procedures, in the opinion of the Principal Investigator.
- Willing to give written consent and adhere to all the requirements of this protocol.
- Female subjects of childbearing potential;
- Non-pregnant and non-lactating females practicing medically acceptable forms of Birth Control and willing to continue during the study.
- Postmenopausal Female- Age > 45 years and Amenorrhea for at least 1 year; or Bilateral Oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months; or Total hysterectomy and an absence of bleeding for at least 3 months.
- Male volunteers must practice protected sex throughout the study.
Who cannot join
- Evidence of allergy or known hypersensitivity to lidocaine, local anesthetics of the amide type e.g., bupivacaine, etidocaine, mepivacaine and prilocaine or to any of the components of formulation.Any major illness in the last three months or any significant chronic medical illness.
- Subjects with history of addiction, abuse, and misuse of any drug - as per physician discretion.
- Subjects with history of mental illness as per physician discretion.
- Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, hepatic, dermatologic, musculoskeletal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the Medical Investigator).
- Participation in any clinical trial within 30 days prior to product application.
- Subjects with inflamed or injured skin, such as active herpes zoster lesions, atopic dermatitis or wounds where the product will be placed.
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- Presence of any skin condition such as scratches, cuts, scars, abrasions, excessive hair, tattoos, moles, recently shaved skin, uneven skin texture, open sores, irritated (redness, rash, or blisters, etc.) or excessively oily skin at the application areas that may affect the application of the study product.
- Use of make-up, creams, lotions, powders, or other topical products to the skin area where the product will be placed, within 48 hours prior to product application.
- Use of antihistamines at product application site within 72 hours prior to product application.
- Using antiarrhythmic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
- Radiation therapy within 3 weeks prior to product application
- History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma etc.) except basal cell carcinomas that were superficial and did not involve the investigative sites.
- Use of nicotine containing products (including e-cigarettes, patches, gum, chewing tobacco, cigars, etc.) within 30 days prior to patch application.
- Positive results for drugs of abuse and alcohol breath analysis prior to product application.
- Female subjects:
- Demonstrating a positive pregnancy screen
- Who are currently breastfeeding
- Use of hormone replacement therapy within three months prior to product application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomized, Four-treatment, Four-sequence, Four-period, Crossover, Single-application Study Evaluating and Comparing Product Adhesion in Healthy Adult Subjects Using ZTlido 1.8% Versus Salonpas(Lidocaine Patch 4%), Aspercreme(Lidocaine Patch 4%) and IcyHot(Lidocaine 4% + Menthol 1% Patch)
The study is designed to evaluate and compare the clinical adhesion performance of the ZTlido (Lidocaine Topical System) 1.8% of Scilex Pharmaceuticals Inc. (Reference) versus Salonpas (Lidocaine Patch 4%), Aspercreme (Lidocaine Patch 4%) and IcyHot (Lidocaine 4% + Menthol 1% Patch), on the Mid to upper back while being worn for 12 hours in healthy adult human subjects.
- Conditions
- Healthy
- Being tested
- ZTlido (Lidocaine Topical System) 1.8%, Salonpas (Lidocaine Patch 4%), Aspercreme (Lidocaine Patch 4%), IcyHot (Lidocaine 4% + Menthol 1% Patch)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZTlido (Lidocaine Topical System) 1.8%Drug
1 ZTlido (Lidocaine Topical System) 1.8% is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours
Salonpas (Lidocaine Patch 4%)Drug
1 Salonpas (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours
Aspercreme (Lidocaine Patch 4%)Drug
1 Aspercreme (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours
IcyHot (Lidocaine 4% + Menthol 1% Patch)Drug
1 IcyHot (Lidocaine 4% + Menthol 1% Patch) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours
| Study group | Role | What they receive |
|---|---|---|
| ZTlido (Lidocaine Topical System) 1.8% | Other | Not described Receives: Drug: ZTlido (Lidocaine Topical System) 1.8% |
| Salonpas (Lidocaine Patch 4%) | Other | Not described Receives: Drug: Salonpas (Lidocaine Patch 4%) |
| Aspercreme (Lidocaine Patch 4%) | Other | Not described Receives: Drug: Aspercreme (Lidocaine Patch 4%) |
| IcyHot (Lidocaine 4% + Menthol 1% Patch) | Other | Not described Receives: Drug: IcyHot (Lidocaine 4% + Menthol 1% Patch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent adhesion
The adhesion performance (i.e., degree of lifting or detachment) is assessed by clinicians at each time point. The adhesion of Test Products 1, 2, and 3 (each over-the-counter external analgesic lidocaine-containing patch) are compared to the adhesion performance observed for the Reference Product.
Measured: 0, 3, 6, 8, 10, and 12 hours
Secondary outcomes (1)
Adverse events
The number of adverse events observed in each treatment will be used to assess the safety and tolerability of the four interventions
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Jul 2021
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized to ZTlido (Lidocaine Topical System) 1.8% or Salonpas (Lidocaine Patch 4%) or Aspercreme (Lidocaine Patch 4%) or IcyHot (Lidocaine 4% + Menthol 1% Patch). Subjects will crossover to each treatment after a wash out period.
- 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
- Dmitri Lissin, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106400
- Sponsor's protocol ID
- A21.1463
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Four-treatment, Four-sequence, Four-period, Crossover, Single-application Study Evaluating and Comparing Product Adhesion in Healthy Adult Subjects Using ZTlido 1.8% Versus Salonpas(Lidocaine Patch 4%), Aspercreme(Lidocaine Patch 4%) and IcyHot(Lidocaine 4% + Menthol 1% Patch)
- ClinicalTrials.gov ID
- NCT05106400
- Acronym / sponsor ID
- A21.1463
- 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
- 1 Jul 2021 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 3 Nov 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 study is designed to evaluate and compare the clinical adhesion performance of the ZTlido (Lidocaine Topical System) 1.8% of Scilex Pharmaceuticals Inc. (Reference) versus Salonpas (Lidocaine Patch 4%), Aspercreme (Lidocaine Patch 4%) and IcyHot (Lidocaine 4% + Menthol 1% Patch), on the Mid to upper back while being worn for 12 hours in healthy adult human subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will be randomized to ZTlido (Lidocaine Topical System) 1.8% or Salonpas (Lidocaine Patch 4%) or Aspercreme (Lidocaine Patch 4%) or IcyHot (Lidocaine 4% + Menthol 1% Patch). Subjects will crossover to each treatment after a wash out period.
| Arm | Type | Receives |
|---|---|---|
| ZTlido (Lidocaine Topical System) 1.8% | Other | Drug: ZTlido (Lidocaine Topical System) 1.8% |
| Salonpas (Lidocaine Patch 4%) | Other | Drug: Salonpas (Lidocaine Patch 4%) |
| Aspercreme (Lidocaine Patch 4%) | Other | Drug: Aspercreme (Lidocaine Patch 4%) |
| IcyHot (Lidocaine 4% + Menthol 1% Patch) | Other | Drug: IcyHot (Lidocaine 4% + Menthol 1% Patch) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy, male and female subjects aged 18 years and older with a Body Mass Index (BMI) range 18.0-32.49 kg/m2 inclusive (according to the formula of BMI = weight (kg) / [height (m)2]).
- Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 28 days of check-in.
- Subjects whose screening laboratory values are within normal limits or considered by the physician or Principal Investigator to be of no clinical significance.
- Absence of disease markers of HIV 1 \& 2, hepatitis B \& C virus.
- Generally healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
Key exclusion criteria (18 listed)
- Evidence of allergy or known hypersensitivity to lidocaine, local anesthetics of the amide type e.g., bupivacaine, etidocaine, mepivacaine and prilocaine or to any of the components of formulation.Any major illness in the last three months or any significant chronic medical illness.
- Subjects with history of addiction, abuse, and misuse of any drug - as per physician discretion.
- Subjects with history of mental illness as per physician discretion.
- Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, hepatic, dermatologic, musculoskeletal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the Medical Investigator).
- Participation in any clinical trial within 30 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 |
|---|---|---|
| ZTlido (Lidocaine Topical System) 1.8%1 ZTlido (Lidocaine Topical System) 1.8% is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours | Drug | ZTlido (Lidocaine Topical System) 1.8% |
| Salonpas (Lidocaine Patch 4%)1 Salonpas (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours | Drug | Salonpas (Lidocaine Patch 4%) |
| Aspercreme (Lidocaine Patch 4%)1 Aspercreme (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours | Drug | Aspercreme (Lidocaine Patch 4%) |
| IcyHot (Lidocaine 4% + Menthol 1% Patch)1 IcyHot (Lidocaine 4% + Menthol 1% Patch) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours | Drug | IcyHot (Lidocaine 4% + Menthol 1% Patch) |
Primary outcome
Change in Percent adhesion
Time frame: 0, 3, 6, 8, 10, and 12 hours
The adhesion performance (i.e., degree of lifting or detachment) is assessed by clinicians at each time point. The adhesion of Test Products 1, 2, and 3 (each over-the-counter external analgesic lidocaine-containing patch) are compared to the adhesion performance observed for the Reference Product.
1 secondary outcome
Adverse events
Time frame: 12 hours
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 3 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Dmitri Lissin, MD study director
Chief Medical Officer
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 ZTlido (Lidocaine Topical System) 1.8%, Salonpas (Lidocaine Patch 4%) and Aspercreme (Lidocaine Patch 4%) 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 13 inclusion and 18 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 3 Nov 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?
Change in Percent adhesion (time frame: 0, 3, 6, 8, 10, and 12 hours). 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 3 Nov 2021.