Iontophoretic Application of Acyclovir Gel to Treat Cold Sores

January 31, 2008 updated by: Transport Pharmaceuticals

A Multicenter, Placebo Controlled, Randomized, Double Blind, Subject Initiated Study of the Safety and Efficacy of the Electrokinetic Transdermal System (ETS) With Acyclovir Gel for the Episodic Treatment of Herpes Labialis

Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels of efficacy due to the limited ability of the drugs to penetrate the skin to the sites where the herpes virus is replicating. Iontophoresis uses electric current to enhance delivery of drugs through the skin. This trial is testing a new iontophoretic device with a new acyclovir gel to treat cold sores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, placebo controlled, randomized, double blind, subject initiated study of the safety and efficacy of a single, 10-minute, topical iontophoretic application of a novel acyclovir 5% gel for the episodic treatment of recurrent herpes labialis. The design of the trial will also allow the comparison of the efficacy of a single iontophoretic treatment with acyclovir gel within 1 hour of first signs and/or symptoms of a herpetic episode to the efficacy of a single iontophoretic treatment with acyclovir gel 6 to18 hours after first signs and/or symptoms. Approximately 810 subjects will be enrolled to treat about 80 subjects in each of three treatment arms. Depending upon how the subject has been randomized into the trial, the subject will receive either: 1) an iontophoretic treatment with active gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with placebo gel; 2) an iontophoretic treatment with placebo gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with active gel; or 3) an iontophoretic treatment with placebo gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with placebo gel. After being enrolled and randomized into the study, subjects will be sent home with a locked kit containing the iontophoretic device with either active or placebo gel. At first signs and/or symptoms of a recurrent herpetic episode (prodromal or erythema), the lesion will be confirmed by telephone interview with the subject and, upon confirmation of the lesion, the subject will be given the combination to the locked kit and instructed to begin treatment immediately. The subject will then be instructed to return to the clinic within 6 to 18 hours of first signs and/or symptoms for a second iontophoretic treatment, appropriate to the treatment arm into which they have been randomized, and an evaluation. The subject will visit the clinic for daily follow-up evaluations for 3 to 14 days following the first treatment and will be called 2 weeks after their last clinic visit for a final safety evaluation.

Study Type

Interventional

Enrollment (Anticipated)

810

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Radiant Research Birmingham
    • California
      • Santa Rosa, California, United States, 95405
        • Radiant Research Santa Rosa
    • Florida
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research St. Petersburg
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Radiant Research Chicago
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Radiant Research Minneapolis
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Radiant Research St. Louis
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Radiant Research Cincinnati
      • Mogadore, Ohio, United States, 44260
        • Radiant Research Akron
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Radiant Research Greer
    • Texas
      • Dallas, Texas, United States, 75231
        • Radiant Research Dallas North
      • San Antonio, Texas, United States, 78229
        • Radiant Research San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subject 18-75 years of age
  2. Female subjects must be using a medically acceptable form of birth control during the study.
  3. Subject must have a history of recurrent herpes labialis and report at least 3 recurrences during the preceding 12 months.
  4. Subject must provide voluntary written informed consent to participate in this study.

Exclusion Criteria:

  1. Subjects with a pacemaker, a history of cardiac arrhythmias or conduction abnormalities.
  2. Any evidence of active malignancy or immunodeficient disease within the last 30 days. Subjects who have completed therapy and are considered unlikely to relapse or who have had surgery and do not have any evidence of disease, are eligible for the study.
  3. Subject requires chronic use of immunomodifying drugs (e.g. systemic steroids) or topical steroids on or near the face; use of inhaled steroids does not exclude a subject from the study.
  4. Subject requires chronic use of anti-viral medication.
  5. History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the gel base.
  6. In females of childbearing potential, a positive urine pregnancy test at time of screening.
  7. Nursing mothers.
  8. Subjects with an implantable electronic device.
  9. Subject has any body piercing in or around the area ordinarily affected by cold sores.
  10. Subject is considered unreliable or unable to understand or follow the protocol directions or is unable to comprehend or satisfactorily assess a herpetic lesion as determined by Investigator or designee at screening.
  11. Subject has abnormal skin conditions (e.g. acne, eczema, psoriasis, albinism, or chronic vesiculobullous disorders) that occur in the area ordinarily affected by cold sores or has significant facial hair in the area of the cold sore that might affect the normal course of the cold sore or might impair accurate evaluation of the cold sore lesion.
  12. Subject has had an infection with HSV-1 isolates know to be resistant to acyclovir, valacyclovir, famciclovir, or ganciclovir.
  13. Subject has had a herpes vaccine.
  14. Subject is currently enrolled in another clinical trial involving the use of a drug and/or a device.
  15. Subject has previously participated in the current study (TPI-H-221).
  16. Subject requires chronic use of analgesics, pain medication or non-steroidal anti-inflammatory agents (NSAIDs).
  17. Subject has a recent history of renal dysfunction or serious hepatic disease.
  18. Subject has a history of alcoholism or drug abuse within the preceding 12 months.
  19. Subject shares a household with another subject already enrolled in the study (TPI-H-221). If the other household member has already completed the study, then the currently enrolling subject is not excluded.
  20. Subject is institutionalized.
  21. Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinician assessed duration of the herpetic episode measured from the time of treatment until the lesion is healed.
Time Frame: Lesion assessments for a minimum of 3 consecutive days and a maximum of 14 days.
Lesion assessments for a minimum of 3 consecutive days and a maximum of 14 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinician assessed: Prevention of progression to a classical lesion;Duration of classical herpetic lesions; Duration of herpetic lesions; Duration of the herpetic lesion hard scab; Duration until complete healing of the herpetic episode;
Time Frame: Lesion assessment for a minimum of 3 consecutive days and a maximum of 14 consecutive days.
Lesion assessment for a minimum of 3 consecutive days and a maximum of 14 consecutive days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transport Pharmaceuticals

Investigators

  • Study Director: Eric M Morrel, PhD, Transport Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 2, 2007

First Submitted That Met QC Criteria

May 2, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2008

Last Update Submitted That Met QC Criteria

January 31, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPI-H-221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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