Postherpetic Neuralgia
Conditions
Keywords
Pain, postherpetic neuralgia
Brief summary
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).
Detailed description
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.
Interventions
DRUGlidocaine and tetracaine cream 7%/7%
One treatment of up to 400 cm2 Cream applied for 60 minutes.
DRUGPlacebo
One treatment of up to 400 cm2 Cream applied for 60 minutes.
Sponsors
ZARS Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of PHN. * Painful PHN areas not located on the face, eye, or in the hair. * At least 3 months post-vesicle crusting.
Exclusion criteria
* Has broken skin at the target treatment site. * Is currently on certain prescription medications. * Doesn't meet criteria due to physical exam findings or medical history. * Female that is pregnant, breastfeeding, or of childbearing potential and not practicing adequate birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 24 hours after treatment |
| Area of allodynia will be mapped at baseline and at the treatment sessions. | 1-2 weeks between study treatments |
| Intensity of allodynia | Baseline, 4 hours, 9 hours, 24 hours after treatment |
| Patient global impression of change. | 9 & 24 hours after treatment |
Countries
United States
Outcome results
None listed