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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine and tetracaine cream 7%/7% | Drug | One treatment of up to 400 cm2 Cream applied for 60 minutes. |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | ZARS Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZARS Pharma Clinical Site | Lexington | Kentucky | 40503 | United States | ||
| ZARS Pharma Clinical Site. Reference: SCP-403 |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | One treatment of up to 400 cm2 Cream applied for 60 minutes. |
|
| High Point |
| North Carolina |
| 27262 |
| United States |
| ZARS Pharma Clinical Site. Reference: SCP-403 | Winston-Salem | North Carolina | 27103 | United States |
| ZARS Pharma Clinical Site | Norman | Oklahoma | 73069 | United States |
| ZARS Pharma Clinical Site | Oklahoma City | Oklahoma | 73112 | United States |
| ZARS Pharma Clinical Site | San Antonio | Texas | 78229 | United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |