Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis
Information source: Transport Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Labialis
Intervention: iontophoretic acyclovir (Device)
Phase: Phase 2
Status: Completed
Sponsored by: Transport Pharmaceuticals Official(s) and/or principal investigator(s):
Christopher M Hull, MD, Principal Investigator, Affiliation: University of Utah
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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 outcome: Clinician assessed prevention of progression to a classical lesionClinician 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. All assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.
Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the
safety and efficacy of iontophoretically-applied acyclovir 5% cream for the treatment of
herpes simplex labialis lesions including an open label arm using Zovirax (acyclovir) Cream
5% as per standard of care in the same patient population. Subjects who meet the eligibility
requirements at the screening/randomization visit will be randomized in a 1: 1:1 ratio to one
of the three treatment groups. 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 cream or a locked kit containing Zovirax Cream 5%. At first signs and/or symptoms
of a recurrent herpetic episode (Stage 0 or 1, 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, thereby initiating the Treatment Phase of the study. Subjects will be followed
for at least 5 consecutive days post-treatment up until a maximum of 10 consecutive days
post-treatment, until the herpes lesion is healed.
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 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.
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, 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.
2. 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.
3. 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.
4. History of allergic or adverse response to acyclovir, or any related anti-viral drug,
or the cream base.
5. In females of childbearing potential, a positive urine pregnancy test at time of
screening.
6. 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.
7. 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).
8. Subject is currently enrolled in another clinical trial or has used an
investigational drug/device within 30 days of enrollment.
9. Subject has previously participated in the current study (TPI-203).
10. Subject has used an anti-viral medication in the preceding 30 days.
11. 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.
12. 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.
13. 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.
14. Subject is institutionalized.
Locations and Contacts
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, Atlanta, Georgia 30342, United States
Radiant Research Atlanta West, Atlanta, Georgia 30308, 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
Additional Information
Sponsor company website
Starting date: April 2005
Last updated: June 30, 2006
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