Iontophoretic Application of Acyclovir Gel to Treat Cold Sores

Completed · Phase 2

Conditions studied: Herpes Labialis

In brief

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.

Key facts

Study ID

NCT00469300

Run by

Transport Pharmaceuticals

People needed

810

Starts

2007-04-01

Expected to finish

2007-10-01

Last updated by the study team

2008-02-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subjects with a pacemaker, a history of cardiac arrhythmias or conduction abnormalities.
• 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.
• 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.
• Subject requires chronic use of anti-viral medication.
• History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the gel base.
• In females of childbearing potential, a positive urine pregnancy test at time of screening.
• Nursing mothers.
• Subjects with an implantable electronic device.
• Subject has any body piercing in or around the area ordinarily affected by cold sores.
• 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.
• 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.
• Subject has had an infection with HSV-1 isolates know to be resistant to acyclovir, valacyclovir, famciclovir, or ganciclovir.
• Subject has had a herpes vaccine.
• Subject is currently enrolled in another clinical trial involving the use of a drug and/or a device.
• Subject has previously participated in the current study (TPI-H-221).
• Subject requires chronic use of analgesics, pain medication or non-steroidal anti-inflammatory agents (NSAIDs).
• Subject has a recent history of renal dysfunction or serious hepatic disease.
• Subject has a history of alcoholism or drug abuse within the preceding 12 months.
• 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.
• Subject is institutionalized.
• Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.

Where it is running

• Radiant Research Birmingham — Birmingham, Alabama, United States
• Radiant Research Santa Rosa — Santa Rosa, California, United States
• Radiant Research St. Petersburg — Pinellas Park, Florida, United States
• Radiant Research Chicago — Chicago, Illinois, United States
• Radiant Research Minneapolis — Edina, Minnesota, United States
• Radiant Research St. Louis — St Louis, Missouri, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• Radiant Research Cincinnati — Cincinnati, Ohio, United States
• Radiant Research Akron — Mogadore, Ohio, United States
• OMEGA Medical Research — Warwick, Rhode Island, United States
• Radiant Research Greer — Greer, South Carolina, United States
• Radiant Research Dallas North — Dallas, Texas, United States
• Radiant Research San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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