NCT00566904

Brief Summary

Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chicken pox. Some people experience continued pain even after the shingles rash and blisters have healed; this pain is known as postherpetic neuralgia. The purpose of this study is to evaluate the effectiveness of a new topical treatment for postherpetic neuralgia in adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

August 31, 2011

Status Verified

August 1, 2011

Enrollment Period

1.9 years

First QC Date

September 10, 2007

Last Update Submit

August 29, 2011

Conditions

Postherpetic Neuralgia

Keywords

Post-herpetic NeuralgiaPain after ShinglesShinglesPHN

Outcome Measures

Primary Outcomes (1)

  • Latency to analgesia onset and duration of analgesia measures

    Between 8 and 16 hours after treatment application

Secondary Outcomes (1)

  • Skin irritation potential

    Between 8 and 24 hours after treatment application

Study Arms (1)

1

EXPERIMENTAL

Participants will receive one of three different topical treatments on Days 8, 15, or 22.

Drug: Epikeia coatings with aspirinDrug: Epikeia coatings with lidocaineOther: Epikeia coatings alone

Interventions

Epikeia coatings with aspirinDRUG

Applied to affected skin area using a roll-on ball applicator

Also known as: Epikeia coatings with acetylsalicylic acid
1
Epikeia coatings with lidocaineDRUG

Applied to affected skin area using a roll-on ball applicator

Also known as: Epikeia coatings with local anesthetic
1
Epikeia coatings aloneOTHER

Applied to affected skin area using a roll-on ball applicator

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In good general health
  • Postherpetic neuralgia, defined as pain persisting more than 4 months after onset of herpes zoster outbreak
  • Willing to use effective forms of contraception for the duration of the study

You may not qualify if:

  • Known lidocaine sensitivity or allergy
  • Inability to discontinue use of any nonstudy lidocaine-containing products for the duration of the study
  • Known hypersensitivity to aspirin
  • Open herpes zoster blisters
  • Known sensitivity or allergy to an amide-type local anesthetic agent
  • Existing conditions that make participation unsafe
  • Pregnant
  • Immunocompromised (e.g., HIV infected)
  • Herpes zoster in any dermatome (area of skin innervated by a specific sensory nerve) affecting the face or scalp
  • Affected skin area is greater than 420 square cm
  • Affected area includes skin breakdown or nonintact skin
  • Affected area consists of more than one contiguous area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Clincial Reseach Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neuralgia, PostherpeticHerpes Zoster

Interventions

AspirinLidocaineAnesthetics, Local

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Adelaide A. Hebert, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2007

First Posted

December 4, 2007

Study Start

September 1, 2006

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

August 31, 2011

Record last verified: 2011-08

Locations

US(1)