A Phase 1 interventional study of Lidocaine topical system 1.8% in Healthy, sponsored by Scilex Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-05.
Sponsored by Scilex Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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.
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.
241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 184 interventional studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →Scilex Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
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.
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.
Drug: Lidocaine topical system 1.8%
lidocaine patch
Also known as: ZTlido
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).
Time frame: Over 12 hours
Peak plasma concentration (Cmax) of lidocaine
Peak plasma concentration of lidocaine after product application for 12 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 24 hours
Area under the plasma concentration versus time curve from 0 to 24 hours of lidocaine in plasma
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
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
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
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.
Time frame: 12.5 and 14 hours post-dose
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Scilex Pharmaceuticals, Inc.