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| Sponsor: | Transport Pharmaceuticals |
|---|---|
| Information provided by: | Transport Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00469300 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Study Director: | Eric M Morrel, PhD | Transport Pharmaceuticals, Inc. |
More Information
| Study ID Numbers: | TPI-H-221 |
| Study First Received: | May 2, 2007 |
| Last Updated: | January 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00469300 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
herpes labialis cold sore acyclovir iontophoresis topical |
|
Herpes Simplex Mouth Diseases Anti-Infective Agents Skin Diseases Lip Diseases Antiviral Agents Pharmacologic Actions Herpesviridae Infections |
Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious Acyclovir Therapeutic Uses DNA Virus Infections Stomatognathic Diseases Herpes Labialis |