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

Study 2022-HZ-011 will utilize 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.

Inclusion Criteria:

1. Subject is a male or female ≥ 18 years of age and ≤ 85 years of age.

2. Subject has brush-evoked allodynic pain intensity score ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.

   a. Onset must have occurred ≤ 20 days prior to randomization

3. Subject has an average daily pain intensity score of ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.

4. Subject must have a diagnosis of herpes zoster (shingles).

5. Subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2.

Exclusion Criteria:

1. Subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas.
2. Subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm2.
3. Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to lidocaine, ingredients of the study drug, or local anesthetics of the amide type.
4. Subject has target skin area (allodynic area and surrounding skin) that is not intact, is inflamed, or in the opinion of the Principal Investigator, consistent with rash due to acute herpes zoster.
5. Subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia.
6. Subject is taking Class I antiarrhythmic drugs (e.g., tocainide, mexiletine), or medications that could interact with the study drug or interfere with its evaluation.