Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome

An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00991068

Enrollment

Registered

2009-10-07

Start date

2009-09-30

Completion date

2010-03-31

Last updated

2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

Pain, Mild to moderate Carpal Tunnel Syndrome

Brief summary

The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.

Detailed description

ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions. The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.

Interventions

DRUGSynera (lidocaine 70 mg and tetracaine 70 mg) topical patch

Patients will apply a single Synera patch to the target wrist for 2 hours twice a day (ie, morning and evening applications) for 14 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pain associated with mild to moderate carpal tunnel syndrome in a single wrist * Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)

Exclusion criteria

* Have bilateral carpal tunnel syndrome * Have another peripheral neuropathy in the affected limb * Have had an injection into the carpal tunnel within 8 weeks * Have had surgical release of the target wrist within previous 6 months * Have electrodiagnostic evidence of severe CTS Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Pain intensity	Screening/Day 1, Day 8, and Day 15 or early withdrawal

Secondary

Measure	Time frame
Pain interference with activities (general, normal work, sleep)	Screening/Day 1, Day 8, and Day 15 or early withdrawal

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026