Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects

Scilex

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lidocaine medicated plaster 5%; Drug: Lidocaine patch 5%; Drug: Lidocaine patch 1.8%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04320173

SCI-LIDO-ADH-002

Details and patient eligibility

About

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%).

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Lidocaine Patch (Sequence ABC)

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine patch 1.8%

Drug: Lidocaine patch 5%

Drug: Lidocaine medicated plaster 5%

Lidocaine Patch (Sequence CAB)

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine patch 1.8%

Drug: Lidocaine patch 5%

Drug: Lidocaine medicated plaster 5%

Lidocaine Patch (Sequences BCA)

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine patch 1.8%

Drug: Lidocaine patch 5%

Drug: Lidocaine medicated plaster 5%