Iontophoretic Application of Acyclovir Gel to Treat Cold Sores
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
1 other identifier
interventional
810
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2007
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 2, 2007
CompletedFirst Posted
Study publicly available on registry
May 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFebruary 4, 2008
January 1, 2008
5 months
May 2, 2007
January 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician assessed duration of the herpetic episode measured from the time of treatment until the lesion is healed.
Lesion assessments for a minimum of 3 consecutive days and a maximum of 14 days.
Secondary Outcomes (1)
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;
Lesion assessment for a minimum of 3 consecutive days and a maximum of 14 consecutive days.
Interventions
Eligibility Criteria
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).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
Related Publications (1)
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. doi: 10.1086/505872. Epub 2006 Jul 3.
PMID: 16838235BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric M Morrel, PhD
Transport Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2007
First Posted
May 4, 2007
Study Start
April 1, 2007
Primary Completion
September 1, 2007
Study Completion
October 1, 2007
Last Updated
February 4, 2008
Record last verified: 2008-01