Postherpetic NeuralgiaPhase 2NCT00609323
Lidocaine and Tetracaine Cream to Treat Postherpetic Neuralgia (PHN)
A Phase 2 study testing lidocaine and tetracaine cream 7%/7% in people with Postherpetic Neuralgia, run by ZARS Pharma Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- lidocaine and tetracaine cream 7%/7%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2008to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of PHN.
- Painful PHN areas not located on the face, eye, or in the hair.
- At least 3 months post-vesicle crusting.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
ZARS Pharma Clinical Site. Reference: SCP-403
High Point, North Carolina, 27262
ZARS Pharma Clinical Site
Lexington, Kentucky, 40503
ZARS Pharma Clinical Site
Norman, Oklahoma, 73069
ZARS Pharma Clinical Site
Oklahoma City, Oklahoma, 73112
ZARS Pharma Clinical Site
San Antonio, Texas, 78229
ZARS Pharma Clinical Site. Reference: SCP-403
Winston-Salem, North Carolina, 27103
About this study
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
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).
Read the 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.
- Conditions
- Postherpetic Neuralgia
- Being tested
- lidocaine and tetracaine cream 7%/7%, Placebo
- Keywords
- Pain, postherpetic neuralgia
- Medical subject headings
- Neuralgia, Postherpetic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine and tetracaine cream 7%/7%Drug
Also called Pliaglis™
One treatment of up to 400 cm2 Cream applied for 60 minutes.
PlaceboDrug
One treatment of up to 400 cm2 Cream applied for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: lidocaine and tetracaine cream 7%/7% |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after treatment
Area of allodynia will be mapped at baseline and at the treatment sessions.
Measured: 1-2 weeks between study treatments
Intensity of allodynia
Measured: Baseline, 4 hours, 9 hours, 24 hours after treatment
Patient global impression of change.
Measured: 9 & 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, ZARS Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609323
- Sponsor's protocol ID
- SCP-403
- Status last verified
- Mar 2012
- First submitted
- 18 Jan 2008
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00609323
- Acronym / sponsor ID
- SCP-403
- Conditions
- Postherpetic Neuralgia
- Keywords
- Pain, postherpetic neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lidocaine and tetracaine cream 7%/7% |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of PHN.
- Painful PHN areas not located on the face, eye, or in the hair.
- At least 3 months post-vesicle crusting.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine and tetracaine cream 7%/7%Also: Pliaglis™One treatment of up to 400 cm2 Cream applied for 60 minutes. | Drug | 1 |
| PlaceboOne treatment of up to 400 cm2 Cream applied for 60 minutes. | Drug | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
ZARS Pharma
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lidocaine and tetracaine cream 7%/7% in people with Postherpetic Neuralgia, run by ZARS Pharma Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2012.