Status:
COMPLETED
Adhesion of Lidocaine Topical System 1.8%
Lead Sponsor:
Scilex Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study is to evaluate the adhesion performance of ZTlido (lidocaine topical system) 1.8% in normal, healthy volunteers.
Detailed Description
In this open-label, single-treatment, single-period, single-application adhesion performance study, 54 healthy, adult male and female subjects are treated with one lidocaine topical system to their ba...
Eligibility Criteria
Inclusion
- Key
- Must be healthy based on by medical history, laboratory work, and physical exam
- 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
- Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
- History of addiction, abuse, and misuse of any drug
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04312750
Start Date
December 1 2015
End Date
December 1 2015
Last Update
March 18 2020
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