Status:
COMPLETED
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects
Lead Sponsor:
Scilex Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2017
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04320173
Start Date
February 14 2017
End Date
March 22 2017
Last Update
March 24 2020
Active Locations (1)
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1
TKL Research, Inc.
Fair Lawn, New Jersey, United States, 07410