Healthy
Conditions
Brief 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%).
Interventions
Three patches are applied to the subject's back for 12 hours.
Three patches are applied to the subject's back for 12 hours.
DRUGLidocaine medicated plaster 5%
Three plasters are applied to the subject's back for 12 hours.
Sponsors
Scilex Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Adhesion Score (FDA scale) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermal Response Score | 12.5 and 14 hours post-dose | 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. |
Countries
United States
Outcome results
None listed