Iontophoretic Application of Acyclovir Gel to Treat Cold Sores

This study has been completed.
Sponsor:
Information provided by:
Transport Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00469300
First received: May 2, 2007
Last updated: January 31, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Herpes Labialis
Drug: Iontophoretic delivery of acyclovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Transport Pharmaceuticals:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 810
Study Start Date: April 2007
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469300

Locations
United States, Alabama
Radiant Research Birmingham
Birmingham, Alabama, United States, 35209
United States, California
Radiant Research Santa Rosa
Santa Rosa, California, United States, 95405
United States, Florida
Radiant Research St. Petersburg
Pinellas Park, Florida, United States, 33781
United States, Illinois
Radiant Research Chicago
Chicago, Illinois, United States, 60610
United States, Minnesota
Radiant Research Minneapolis
Edina, Minnesota, United States, 55435
United States, Missouri
Radiant Research St. Louis
St. Louis, Missouri, United States, 63141
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, Ohio
Radiant Research Cincinnati
Cincinnati, Ohio, United States, 45236
Radiant Research Akron
Mogadore, Ohio, United States, 44260
United States, Rhode Island
OMEGA Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Radiant Research Greer
Greer, South Carolina, United States, 29651
United States, Texas
Radiant Research Dallas North
Dallas, Texas, United States, 75231
Radiant Research San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Transport Pharmaceuticals
Investigators
Study Director: Eric M Morrel, PhD Transport Pharmaceuticals, Inc.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00469300     History of Changes
Other Study ID Numbers: TPI-H-221
Study First Received: May 2, 2007
Last Updated: January 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Transport Pharmaceuticals:
herpes labialis
cold sore
acyclovir
iontophoresis
topical

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014