Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis
A Multicenter, Placebo Controlled, Randomized, Double Blind, Subject Initiated Study of the Safety and Efficacy of a Single Topical Iontophoretic Application of Acyclovir 5% Cream With an Open Label Conventional Therapy Treatment Arm, and a Blinded Evaluator, for the Treatment of Recurrent Herpes Labialis
1 other identifier
interventional
1,800
1 country
26
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 site where the herpes virus is replicating. Iontophoresis uses electric current to enhance the delivery of drugs through the skin. This trial is testing a new iontophoretic device for the delivery of acyclovir cream 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 2005
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 29, 2005
CompletedFirst Posted
Study publicly available on registry
October 3, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJuly 4, 2006
June 1, 2006
September 29, 2005
June 30, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician assessed duration of the herpetic episode measured from time of treatment until lesion healed. Lesion assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.
Secondary Outcomes (6)
Clinician assessed prevention of progression to a classical lesion
Clinician assessed duration of classical herpetic lesions.
Clinician assessed duration of the herpetic lesion (aborted lesions will be assigned a duration of lesion value of 0 for the purposes of the statistical analysis).
Clinician assessed duration of the herpetic lesion hard scab.
Examine the safety of iontophoretic application of acyclovir 5% cream.
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subject 18-75 years of age
- Female subject must be using a medically acceptable form of birth control during the study. Acceptable birth control measures are abstinence, oral contraceptive pills or patch, injectable contraception, barrier contraceptives (condom, diaphragm with spermicide), IUD, surgical (hysterectomy, tubal ligation), vasectomized partner, or natural post menopausal inability to conceive.
- 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, or a history of cardiac arrhythmias or conduction abnormalities. Any subject with a medically confirmed history of cardiac arrhythmia including sinus arrhythmia, premature beat, heart block, atrial fibrillation, atrial flutter and pulsus alternans is to be excluded from the study.
- Any evidence of active malignancy, immunodeficient disease, or use of immunomodifying drugs (e.g., systemic steroids) within 30 days prior to enrollment. 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.
- Subjects using topical steroids on or near the face or systemic (oral, intravenous) steroids within 30 days of enrollment; use of inhaled steroids does not exclude a subject from the study.
- History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the cream base.
- In females of childbearing potential, a positive urine pregnancy test at time of screening.
- Subject is considered unreliable or unable to understand or follow the protocol directions or is unable to comprehend or satisfactorily use the measurement scales as determined by investigator or designee at screening.
- Subject has abnormal skin conditions that occur in the area ordinarily affected by cold sores which might affect the normal course of cold sores (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).
- Subject is currently enrolled in another clinical trial or has used an investigational drug/device within 30 days of enrollment.
- Subject has previously participated in the current study (TPI-203).
- Subject has used an anti-viral medication in the preceding 30 days.
- Subject requires chronic use of analgesics, pain medication or non-steroidal anti-inflammatory agents (NSAIDs). If a subject is unlikely to get through the treatment phase of the protocol without requiring the use of analgesia for a chronic condition, e.g. back pain, recurrent daily headaches, the subject should be excluded.
- Subject has a recent history of renal dysfunction or serious hepatic disease. Renal dysfunction encompasses both acute and chronic renal failure, the former resulting from the sudden loss of the ability of the kidneys to excrete wastes, concentrate urine, and conserve electrolytes and the latter the gradual and progressive loss of these capabilities. Examples of serious hepatic disease would include alcoholic liver disease, chronic hepatitis, autoimmune hepatitis and a variety of inherited diseases. The underlying cause of a documented recent mild increase in liver enzymes should be considered when deciding whether or not to exclude such a subject.
- Subject has a history of alcoholism or drug abuse within the preceding 12 months. A subject with a history of a pathological pattern of alcohol use that causes a serious impairment of social or occupational functioning should be excluded. Such subjects may exhibit symptoms of tolerance and withdrawal along with other behavioral symptoms.
- Subject is institutionalized.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Radiant Research Birmingham
Birmingham, Alabama, 35209, United States
Radiant Research Phoenix Southeast
Chandler, Arizona, 85225, United States
Radiant Research Phoenix
Phoenix, Arizona, 85013, United States
Radiant Research Scottsdale
Scottsdale, Arizona, 85251, United States
Radiant Research San Diego
San Diego, California, 92123, United States
Radiant Research Santa Rosa
Santa Rosa, California, 95405, United States
Radiant Research St. Petersburg
Pinellas Park, Florida, 33781, United States
Radiant Research Stuart
Stuart, Florida, 34996, United States
Radiant Research West Palm
West Palm Beach, Florida, 33407, United States
Radiant Research Atlanta West
Atlanta, Georgia, 30308, United States
Radiant Research Atlanta
Atlanta, Georgia, 30342, United States
Radiant Research Boise
Boise, Idaho, 83704, 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
Pediatric Clinical Trials International
Columbus, Ohio, 43205, United States
Radiant Research Philadelphia
Philadelphia, Pennsylvania, 19115, United States
Radiant Research Greer
Greer, South Carolina, 29651, United States
J & S Studies, Inc.
Bryan, Texas, 77802, United States
Radiant Research Dallas North
Dallas, Texas, 75231, United States
Radiant Research San Antonio
San Antonio, Texas, 78229, United States
Univeristy of Utah Health Sciences
Salt Lake City, Utah, 84132, United States
Dermatology & Laser Center NW
Bellingham, Washington, 98225, United States
Radiant Research Tacoma
Lakewood, Washington, 98499, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher M Hull, MD
University of Utah
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
September 29, 2005
First Posted
October 3, 2005
Study Start
April 1, 2005
Study Completion
December 1, 2005
Last Updated
July 4, 2006
Record last verified: 2006-06