Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)
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| ClinicalTrials.gov Identifier: NCT00609323 |
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Recruitment Status :
Completed
First Posted : February 7, 2008
Last Update Posted : March 29, 2012
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postherpetic Neuralgia | Drug: lidocaine and tetracaine cream 7%/7% Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 23 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Crossover Study Comparing Pliaglis™ (Lidocaine and Tetracaine) Cream 7%/7% to Placebo Cream When Applied for 60 Minutes in the Treatment of Patients With Postherpetic Neuralgia |
| Study Start Date : | January 2008 |
| Actual Primary Completion Date : | July 2008 |
| Actual Study Completion Date : | September 2008 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: lidocaine and tetracaine cream 7%/7%
One treatment of up to 400 cm2 Cream applied for 60 minutes.
Other Name: Pliaglis™ |
| Placebo Comparator: 2 |
Drug: Placebo
One treatment of up to 400 cm2 Cream applied for 60 minutes. |
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609323
| United States, Kentucky | |
| ZARS Pharma Clinical Site | |
| Lexington, Kentucky, United States, 40503 | |
| United States, North Carolina | |
| ZARS Pharma Clinical Site. Reference: SCP-403 | |
| High Point, North Carolina, United States, 27262 | |
| ZARS Pharma Clinical Site. Reference: SCP-403 | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Oklahoma | |
| ZARS Pharma Clinical Site | |
| Norman, Oklahoma, United States, 73069 | |
| ZARS Pharma Clinical Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Texas | |
| ZARS Pharma Clinical Site | |
| San Antonio, Texas, United States, 78229 | |
| Study Director: | Medical Monitor | ZARS Pharma |
| Responsible Party: | ZARS Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT00609323 History of Changes |
| Other Study ID Numbers: |
SCP-403 |
| First Posted: | February 7, 2008 Key Record Dates |
| Last Update Posted: | March 29, 2012 |
| Last Verified: | March 2012 |
Keywords provided by ZARS Pharma Inc.:
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Pain postherpetic neuralgia |
Additional relevant MeSH terms:
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Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Lidocaine Tetracaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |