NCT05106400

Clinical Adhesion Study Between ZTlido 1.8% and Three Over-the-counter External Analgesic Lidocaine-containing Patches

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Scilex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 being worn for 12 hours in healthy adult human subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	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	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	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	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

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2021-11-03
• Last updated: 2021-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study