Pliaglis™ (lidocaine and tetracaine) Cream 7%/7% is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. When applied to intact skin, Pliaglis provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into the skin. Pliaglis is currently approved in the United States for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, and facial laser resurfacing. This study will evaluate lidocaine and tetracaine cream 7%/7% for the treatment of pain associated with postherpetic neuralgia (PHN).
The objectives of the study are 1) to compare the clinical efficacy of lidocaine and tetracaine cream 7%/7% with placebo cream in the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and 2) to monitor the nature and frequency of adverse events following a single, 60-minute application of lidocaine and tetracaine cream 7%/7% and placebo cream.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
One treatment of up to 400 cm2 Cream applied for 60 minutes.
One treatment of up to 400 cm2 Cream applied for 60 minutes.
ZARS Pharma Clinical Site
Lexington, Kentucky, United States
ZARS Pharma Clinical Site. Reference: SCP-403
High Point, North Carolina, United States
ZARS Pharma Clinical Site. Reference: SCP-403
Winston-Salem, North Carolina, United States
ZARS Pharma Clinical Site
Norman, Oklahoma, United States
ZARS Pharma Clinical Site
Oklahoma City, Oklahoma, United States
ZARS Pharma Clinical Site
San Antonio, Texas, United States
Pain will be rated using the Numeric Pain Rating Scale (NPRS). Patients will rate: Worst pain over the last 24 hours, Least pain over the last 24 hours, Average pain over the last 24 hours, Present pain intensity.
Time frame: 24 hours after treatment
Area of allodynia will be mapped at baseline and at the treatment sessions.
Time frame: 1-2 weeks between study treatments
Intensity of allodynia
Time frame: Baseline, 4 hours, 9 hours, 24 hours after treatment
Patient global impression of change.
Time frame: 9 & 24 hours after treatment
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