Iontophoretic Application of Acyclovir Gel to Treat Cold Sores

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Transport Pharmaceuticals
• Treatments: Acyclovir

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.