Overview
Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)
Status:
Completed
Completed
Trial end date:
2008-09-01
2008-09-01
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
ZARS Pharma Inc.Treatments:
Lidocaine
Tetracaine
Criteria
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.