HealthyPhase 1NCT04320173
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects
A Phase 1 study testing Lidocaine patch 1.8%, Lidocaine patch 5% and Lidocaine medicated plaster 5% in people with Healthy, run by Scilex Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 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 patch 1.8%, Lidocaine patch 5% and Lidocaine medicated plaster 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2017to 22 Mar 2017
- 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, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
- Non-smokers
- 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
- Presence of any current dermatological condition including psoriasis, eczema, and atopic dermatitis
- Presence of any skin condition such as scratches, cuts, scars, abrasions, excessive hair, tattoos, moles, recently shaved skin, uneven skin texture, irritated (e.g., redness, rash or having blister, etc.) or excessively oily skin at the application areas that may affect the application of the product or adhesion properties of the product.
- History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and do not involve the investigative site
- History of addiction, abuse, and misuse of any drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Three-period, Single-application, Adhesion Performance Study ZTlido® (Lidocaine Topical System) 1.8% Compared to Lidoderm® (Lidocaine Patch 5%) and Versatis® (Lidocaine Medicated Plaster 5%) in Healthy, Adult, Human Subjects
The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).
- Conditions
- Healthy
- Being tested
- Lidocaine patch 1.8%, Lidocaine patch 5%, Lidocaine medicated plaster 5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patch 1.8%Drug
Also called Lidocaine topical system 1.8%, ZTlido
Three patches are applied to the subject's back for 12 hours.
Lidocaine patch 5%Drug
Also called Lidoderm
Three patches are applied to the subject's back for 12 hours.
Lidocaine medicated plaster 5%Drug
Also called Versatis
Three plasters are applied to the subject's back for 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Patch (Sequence ABC) | Experimental | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied in Period 1, and 3 lidocaine 5% patches were applied in Period 2, and 3 lidocaine 5% medicated plasters were applied in Period 3. Receives: Drug: Lidocaine patch 1.8%; Drug: Lidocaine patch 5%; Drug: Lidocaine medicated plaster 5% |
| Lidocaine Patch (Sequence CAB) | Experimental | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 2, 3 lidocaine 5% medicated plasters were applied in Period 1, and 3 lidocaine 1.8% patches were applied in Period 2, and 3 lidocaine 5% patches were applied in Period 3. Receives: Drug: Lidocaine patch 1.8%; Drug: Lidocaine patch 5%; Drug: Lidocaine medicated plaster 5% |
| Lidocaine Patch (Sequences BCA) | Experimental | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 3, 3 lidocaine 5% patches were applied in Period 1, and 3 lidocaine 5% medicated plasters were applied in Period 2, and 3 lidocaine 1.8% patches were applied in Period 3. Receives: Drug: Lidocaine patch 1.8%; Drug: Lidocaine patch 5%; Drug: Lidocaine medicated plaster 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Adhesion Score (FDA scale)
Adhesion of the product to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion 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). Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.
Measured: 12 hours post-dose
Mean Adhesion Score (EMA scale)
Adhesion of the product to the skin is assessed by the EMA 0-6 scoring system. The scoring for adhesion is indicated as follows: 0 = < 70% Adhered, 1 = > 70% Adhered, 2 = > 75% Adhered, 3 = > 80% Adhered, 4 = > 85% Adhered, 5 = > 90% adhered, and 6 = > 95% Adhered. Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.
Measured: 12 hours post-dose
Secondary outcomes (1)
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 posted24 Mar 2020
- Study start14 Feb 2017
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scilex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip LaStella, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320173
- Sponsor's protocol ID
- SCI-LIDO-ADH-002
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Three-period, Single-application, Adhesion Performance Study ZTlido® (Lidocaine Topical System) 1.8% Compared to Lidoderm® (Lidocaine Patch 5%) and Versatis® (Lidocaine Medicated Plaster 5%) in Healthy, Adult, Human Subjects
- ClinicalTrials.gov ID
- NCT04320173
- Acronym / sponsor ID
- SCI-LIDO-ADH-002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Scilex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (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.
The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Patch (Sequence ABC) | Experimental | Drug: Lidocaine patch 1.8%, Drug: Lidocaine patch 5%, Drug: Lidocaine medicated plaster 5%Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied in Period 1, and 3 lidocaine 5% patches were applied in Period 2, and 3 lidocaine 5% medicated plasters were applied in Period 3. |
| Lidocaine Patch (Sequence CAB) | Experimental | Drug: Lidocaine patch 1.8%, Drug: Lidocaine patch 5%, Drug: Lidocaine medicated plaster 5%Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 2, 3 lidocaine 5% medicated plasters were applied in Period 1, and 3 lidocaine 1.8% patches were applied in Period 2, and 3 lidocaine 5% patches were applied in Period 3. |
| Lidocaine Patch (Sequences BCA) | Experimental | Drug: Lidocaine patch 1.8%, Drug: Lidocaine patch 5%, Drug: Lidocaine medicated plaster 5%Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 3, 3 lidocaine 5% patches were applied in Period 1, and 3 lidocaine 5% medicated plasters were applied in Period 2, and 3 lidocaine 1.8% patches were applied in Period 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be healthy based on by medical history, laboratory work, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
- Non-smokers
- 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 (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
- Presence of any current dermatological condition including psoriasis, eczema, and atopic dermatitis
- Presence of any skin condition such as scratches, cuts, scars, abrasions, excessive hair, tattoos, moles, recently shaved skin, uneven skin texture, irritated (e.g., redness, rash or having blister, etc.) or excessively oily skin at the application areas that may affect the application of the product or adhesion properties of the product.
- History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and do not involve the investigative site
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 patch 1.8%Also: Lidocaine topical system 1.8%, ZTlidoThree patches are applied to the subject's back for 12 hours. | Drug | Lidocaine Patch (Sequence ABC), Lidocaine Patch (Sequence CAB), Lidocaine Patch (Sequences BCA) |
| Lidocaine patch 5%Also: LidodermThree patches are applied to the subject's back for 12 hours. | Drug | Lidocaine Patch (Sequence ABC), Lidocaine Patch (Sequence CAB), Lidocaine Patch (Sequences BCA) |
| Lidocaine medicated plaster 5%Also: VersatisThree plasters are applied to the subject's back for 12 hours. | Drug | Lidocaine Patch (Sequence ABC), Lidocaine Patch (Sequence CAB), Lidocaine Patch (Sequences BCA) |
Primary outcome
Mean Adhesion Score (FDA scale)
Time frame: 12 hours post-dose
Adhesion of the product to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion 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). Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.
Mean Adhesion Score (EMA scale)
Time frame: 12 hours post-dose
Adhesion of the product to the skin is assessed by the EMA 0-6 scoring system. The scoring for adhesion is indicated as follows: 0 = < 70% Adhered, 1 = > 70% Adhered, 2 = > 75% Adhered, 3 = > 80% Adhered, 4 = > 85% Adhered, 5 = > 90% adhered, and 6 = > 95% Adhered. Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.
1 secondary outcome
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 24 Mar 2020.
- 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.
- Individual participant dataSharing planned: Yes
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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.
Phillip LaStella, MD principal investigator
TKL Research, Inc.
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 patch 1.8%, Lidocaine patch 5% and Lidocaine medicated plaster 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 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 24 Mar 2020. 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 Adhesion Score (FDA scale) (time frame: 12 hours post-dose). The study lists 2 primary outcomes in all. 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 NCT04320173, 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 Mar 2020.