A Phase 1 interventional study of lidocaine topical system 1.8% and lidocaine patch 5% in Healthy, sponsored by Scilex Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Scilex Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%
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:
Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 1, lidocaine 1.8% topical systems are applied in Period 1, and the generic lidocaine 5% patches are applied in Period 2.
Drug: lidocaine topical system 1.8% · Drug: lidocaine patch 5%
Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 2, generic lidocaine 5% patches are applied in Period 1, and the lidocaine 1.8% topical systems are applied in Period 2.
Drug: lidocaine topical system 1.8% · Drug: lidocaine patch 5%
One topical system is applied to the subject's back for 12 hours.
Also known as: lidocaine patch 1.8%, ZTlido
One generic lidocaine patch is applied to the subject's back for 12 hours.
Mean Percent Adhesion
Percent adhesion is assessed by laying a transparent sheet the exact size of the product over the top of the product and outlining areas of adhesion with a marker on the transparent sheet. The area excluded from the adhered area will be assessed to determine the degree of lift-off. Adhesion is assessed every 3 hours after product application. Mean percent adhesion is calculated as the sum of scores at each assessment time point divided by the total number of observations.
Time frame: 12 hours post-dose
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Scilex Pharmaceuticals, Inc.