Iontophoretic Application of Acyclovir Gel to Treat Cold Sores
Information source: Transport Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Labialis
Intervention: Iontophoretic delivery of acyclovir (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Transport Pharmaceuticals Official(s) and/or principal investigator(s):
Eric M Morrel, PhD, Study Director, Affiliation: Transport Pharmaceuticals, Inc.
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinician assessed duration of the herpetic episode measured from the time of treatment until the lesion is healed.
Secondary outcome: 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;
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Radiant Research Birmingham, Birmingham, Alabama 35209, United States
Radiant Research Santa Rosa, Santa Rosa, California 95405, United States
Radiant Research St. Petersburg, Pinellas Park, Florida 33781, United States
Radiant Research Chicago, Chicago, Illinois 60610, United States
Radiant Research Minneapolis, Edina, Minnesota 55435, United States
Radiant Research St. Louis, St. Louis, Missouri 63141, United States
Rochester Clinical Research, Inc., Rochester, New York 14609, United States
Radiant Research Cincinnati, Cincinnati, Ohio 45236, United States
Radiant Research Akron, Mogadore, Ohio 44260, United States
OMEGA Medical Research, Warwick, Rhode Island 02886, United States
Radiant Research Greer, Greer, South Carolina 29651, United States
Radiant Research Dallas North, Dallas, Texas 75231, United States
Radiant Research San Antonio, San Antonio, Texas 78229, United States
Additional Information
Mayo Clinic Cold Sore Information
Related publications: Morrel EM, Spruance SL, Goldberg DI; Iontophoretic Acyclovir Cold Sore Study Group. Topical iontophoretic administration of acyclovir for the episodic treatment of herpes labialis: a randomized, double-blind, placebo-controlled, clinic-initiated trial. Clin Infect Dis. 2006 Aug 15;43(4):460-7. Epub 2006 Jul 3.
Starting date: April 2007
Ending date: October 2007
Last updated: January 31, 2008
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