RecruitingACTRN12615000033549

Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared with Placebo in Subjects With Acute Herpes Zoster (Shingles) Pain

A Phase Ib Pilot Multiple Dose, Randomized-Withdrawal, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared with Placebo in Subjects With Acute Herpes Zoster Pain


Sponsor

Centrexion Corporation

Enrollment

16 participants

Start Date

Dec 11, 2014

Study Type

Interventional

Conditions

Summary

A study utilizing a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a high-strength lidocaine gel (40%) applied to the skin to relieve pain from shingles (herpes zoster). Shingles causes a painful rash and can lead to severe nerve pain. The gel is applied directly to the area where you feel the allodynia — a type of pain where even light touch, like brushing clothing against the skin, is very painful. Participants are randomly assigned to use either the lidocaine gel or a placebo gel and researchers track how their pain changes. You may be eligible if: - You are between 18 and 85 years old - You have been diagnosed with shingles (herpes zoster) - Your rash appeared within the last 20 days - Your rash is on your trunk or limbs (not face, head, neck, or genital area) and covers less than 300 cm2 - Your pain score is 4 or above out of 10 You may NOT be eligible if: - Your shingles rash is on your face, head, neck, or genital/rectal areas - You are allergic to lidocaine or local anaesthetics - The rash area is broken, inflamed, or not intact - You take Class I antiarrhythmic heart medications Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Application of 1mL CTNX-2022 (40% Anhydrous Lidocaine Gel) or placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.

Application of 1mL CTNX-2022 (40% Anhydrous Lidocaine Gel) or placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.


Locations(1)

VIC, Australia

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ACTRN12615000033549